BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOSE 201+ ANALYZER

    MDR report key: 4563434 · Received February 26, 2015

    Report

    Report Number
    3003044483-2015-00010
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    January 12, 2015
    Report Date
    January 27, 2015
    Manufacturer
    HEMOCUE AB
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE GLUCOSE 201+ SYSTEM IS NOT ON THE US MARKET; HOWEVER, A SIMILAR SYSTEM, THE GLUCOSE 201 SYSTEM, IS AVAILABLE ON THE US MARKET, 510 (K) # K020935. THE INVESTIGATION IS STILL ONGOING, THUS NO CAUSE HAS YET BEEN DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT CONCERNED A GLUCOSE 201+ ANALYZER (A) THAT ON SOME OCCASIONS HAS SHOWED DEVIATING RESULTS WHEN COMPARED TO ANOTHER HEMOCUE GLUCOSE 201+ ANALYZER (B). THE (A) ANALYZER WAS USED ON NEONATES AND IT SHOWED CONSISTENTLY LOWER RESULTS THAN THE OTHER ANALYZER. NO PT IMPACT IS REPORTED. A FALSE LOW RESULT COULD POTENTIALLY LEAD TO AN UNNECESSARY MED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137715 GLUCOSE 201+ ANALYZER HEMOCUE GLUCOSE 201+ ANALYZER CGA HEMOCUE AB 110718 1410541

    Patients

    Seq Age Sex Outcome Treatment
    1