Events

Safety Alert for NON-SPECIFIC SYSTEMS FOR GLYCOSIS - MEASURING DEVICES AND RIBBON TESTS OF GLYCOSYDYDROGENASE WITH PYRROLOQUINONE QUINONE (GDH-PQQ) from all manufacturers.

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
    992
  • Date
    2009-10-08
  • 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
    Non-glucose sugars capable of interfering with the GDH-PQQ reagent strips may appear in biological products and medicinal products or may result from the metabolism of another product. GDH-PQQ reagent strips do not distinguish glucose from other sugars. Of the 13 deaths due to excessive insulin administration in the United States, reported to the FDA between 1997 and 2009 involving this problem, some indicated hypoglycemia, confusion, neurological deterioration, severe hypoxia, brain damage and or coma before death. Sugar products other than glucose involved in these reports include Extranel (icodextrin), Potacor R, Octagam and an infusion containing maltose. More products may interfere with the results: Orencia (Abatacept), Gamimune N 5%, WinRho SDF Liquid, Vaccine Immune Globulin Intravenous (human), HepaGam N, Bexxat (radioimmunotherapy agent) Adept adhesion reduction solution (4% icodextrin) and any product which contains or is metabolized in maltose, galactose or xylose. No occurrences have been reported in Brazil until the present date.
  • Reason
    The fda, through studies from 1997 to 2009, reports that the use of glucose dehydrogenase reagent strips with pyrroloquinoline quinone (gdh-pqq) in health units, in patient blood samples containing certain sugars other than glucose (eg maltose, xylose, galactose), may produce false high glucose results, which may indicate a clinical measure. this problem may cause inappropriate dosing and administration of insulin, possibly resulting in hypoglycemia, coma, or death. such a problem may also mask true hypoglycemia if the patient and the health care provider rely solely on the measurement results with gdh-pqq glucose reactant tapes.
  • Action
    Recommendations to users are as follows: (1) Avoid the use of GDH-PQQ reagent tapes in health facilities performing peritoneal dialysis; (2) If your health care facility uses GDH-PQQ reagent tapes, do not use them in patients who are receiving interfering products or patients whom you can not obtain information about using concomitant medications (eg patients non-responsive, patients unable to communicate); (3) Check, at the time of admission and periodically during hospitalization, whether patients are receiving incompatible products; (4) Inform staff and patients of the potential for false high readings in the presence of certain sugars other than glucose with GDH-PQQ reagent tapes; (5) Consider implementing drug interaction alerts in computerized patient record systems, charts, and patient charts to alert staff to the potential for false high glucose results; (6) Periodically check the results of the glycosimeter with laboratory tests. (7) Notify the National Health Surveillance System of any problems occurring in your health facility.

Device

NON-SPECIFIC SYSTEMS FOR GLYCOSIS - MEASURING DEVICES AND RIBBON TESTS OF GLYCOSYDYDROGENASE WITH...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA