Events

Field Safety Notices about MultiCareTM Analyzer/Lumiratek C

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by SD Biosensor.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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  • Type of Event
    Field Safety Notice
  • Date
    2017-09-07
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
    Transmission of this Field Safety Notice to all affected countries: UK, Italy, Slovenia, Germany, Belgium, Switzerland, Danmark, Sweden ∎ Contact reference person EEA Distributor Representative Phone E-mail address UK Lumira Claire Alexander +441241-439020 claire.alexander@lumiradx.com ITALY Iris Medical SRL Francesco Mitolo +393735416735 fmitolo@a-ps.it SLOVENIA Drasen Lab d.o.o Robert Pal +386 (0)68 66 53 14 info@drasenlab.com GERMANY Lumira Uwe Klimpe +491728123263 uwe.klimpe@lumiradx.com
  • Reason
    Problem: in case of the measurement of crp and u-albumin items using the multicaretm analyzer/lumiratek c, the analyzer shows the result of “lo” first correctly, however, the result is recorded “hi” instead “lo” in the memory. so, stored results are display incorrectly in review mode. however, there is no problem with the first displayed results that are displayed first, except for the results stored. we have conducted an activity to identify the cause of this problem and confirmed that it is caused by a software bug in the analyzer. - potential risk to patient: the analyzer reads u-albumin concentration between 5.0-300mg/l, crp concentration between 3.0-150mg/l for capillary or venous whole blood sample and 3.0-120mg/l for plasma or serum sample. and if the test result is out of the measurement range, the analyzer displays ‘lo’ message or ‘hi’ message. in crp or u-albumin measurements, if the patient's measurement result is indicated as 'lo', which means that the concentration of the crp or u-albumin is low, at the same time the patient is normal. furthermore, it is less likely that a person who is considered to be a patient is likely to display the results of the 'lo' measurement. however, if the measurement result of 'lo' is displayed and you have confirmed it as the result stored in the review mode, incorrect diagnosis, prescription and treatment may be made. for example, antibiotics or kidney medicines may be prescribed to normal people. this can cause adverse drug reactions.

Device

MultiCareTM Analyzer/Lumiratek C
  • Model / Serial
    MA0116001~007 / MA0117001~010
  • Product Description
    Semi-automated I.A Systems. The MultiCare TM system/LumiratechC is a reflectometry immunoassay instrument for the quantitative measurement in human blood, urine and other specimens. This system is for in vitro diagnostic use and professional use in hospital and clinic.
  • Manufacturer
    SD Biosensor

Manufacturer

SD Biosensor
  • Manufacturer Address
    C-4th&5th, 16, Deogyeong-dearo 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC OF KOREA Tel 82-31-300-0400 Fax 82-31-300-0499 http://www.sdbiosensor.com
  • Manufacturer Parent Company (2017)
    Sd Biosensor Inc.
  • Source
    AMPMDRS