Events

Safety Alert for NON-SPECIFIC SYSTEMS FOR GLYCOSIS - DEVICES FOR MEASURING AND REAGENT RAYS OF GLYCOSYDIDROGENASE WITH PYRROLOQUINONE QUINONE (GDH-PQQ) OR MUT Q-GDH. [ALERT UPDATED ON 07/09/2015]. [ALERT UPDATED ON 08/17/2015]. [ALERT UPDATED ON 08/26/2015].

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1596
  • Date
    2015-06-02
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Reactive ribbons based on the enzyme Pyrroloquinone Dehydrogenase Pyrroloquinone Quinone (GDH-PQQ) may lead to false high glucose concentration results in blood samples containing certain sugars other than glucose (maltose, xylose or galactose, for example), given low selectivity for glucose. Mutant variations of GDH-PQQ (mut. Q-GDH) may also undergo galactose interference, which may lead to falsely elevated glucose results in the same way. False high glucose results may lead to an incorrect diagnosis of hyperglycaemia and, sequentially, inappropriate dosing / administration of insulin to the patient, leading to hypoglycemia, coma, or death. False high glucose results can also mask true hypoglycemia. Galactosemia is a metabolic deficiency that causes an increased concentration of galactose in the blood. There is no conclusive study on the frequency of galactosemia in Brazil as a whole; however, a pilot study conducted in the state of São Paulo with 59,953 newborns (10% of all live births in 2006) has identified an incidence of galactosemia of around 1: 20,000 newborns. According to references cited in this study, estimates of the frequency of galactosemia in the world are variable - between 1: 100,000 (Asia) and 1: 14,000 (South Africa). The use of reagent tapes based on GDH-PQQ, or mut Q-GDH, on blood samples from patients with galactosemia may lead to misdiagnosis of high glucose and consequent serious adverse events resulting from inappropriate insulin administration. The risk of serious adverse events may be even greater in the case of neonates with galactosemia, due to the low communication capacity of these patients. In addition, newborns are not routinely tested for galactosemia soon after birth - the test for this alert supplements earlier warning information regarding GDH-PQQ technology, published in 2009: Technovigilance Alert # 992, available at http: //www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;=992. Other important references: See field SOURCE of this alert. [ALERT UPDATED ON 07/09/2015]. [ALERT UPDATED ON 08/17/2015]. [ALERT UPDATED ON 08/26/2015].
  • Reason
    The use of reagent strips based on gdh-pqq or mut. q-gdh may lead to falsely elevated glucose results in blood samples containing excess galactose, which poses a risk for patients with galactosemia (increased galactose in the blood, usually caused by a metabolic deficiency). this situation is more critical for neonates due to the limited communication capacity of these patients, and since the test for the detection of galactosemia is not a standardized test in health facilities.
  • Action
    Recommendations to users and patients: (1) The use of reagent tapes based on GDH-PQQ technology, or mut. Q-GDH (variation of GDH-PQQ) in blood samples from patients with galactosemia may lead to misinterpretations of high glucose and inappropriate insulin administration; (2) Try to familiarize yourself with the reagent tapes you use, seeking to identify the technology used. Use the instructions for use of the product as a first reference; (3) Do not use reagent tapes based on GDH-PQQ or mut. Q-GDH in patients with galactosemia. These reagent tapes should also not be used in neonates with suspected galactosemia - alternative methods of glycemia should be used in these cases; (4) If in doubt, contact the manufacturer of the product or seek advice from your doctor; (5) Refer to Technovigilance alert # 992 for other risk situations involving reagent tapes based on GDH-PQQ technology and its interference with maltose; (6) When using products based on other blood glucose measurement technologies, make sure these products are indicated for use in newborns (refer to the user / operator's manual) and additionally take into account interferents that affect such technologies. which can also lead to false results of blood glucose concentration; (7). This is a safety alert aimed at highlighting the risk of using the product in a patient-specific clinical condition (galactosemia). The intention is that the information be used to optimize the risk management of the product in health services. That is, the Alert does not define the collection and does not prohibit the use of products based on such technologies, but rather informs specific risk situations that must be evaluated and managed by those who prescribe and use such reagent tapes.

Device

NON-SPECIFIC SYSTEMS FOR GLYCOSIS - DEVICES FOR MEASURING AND REAGENT RAYS OF GLYCOSYDIDROGENASE ...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA