BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201+ ANALYZER

    MDR report key: 2121895 · Received May 23, 2011

    Report

    Report Number
    3003044483-2011-00001
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 23, 2011
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HEMOCUE GLUCOSE 201 + ANALYZER IS NOT MARKETED IN THE US. A SIMILAR DEVICE, THE HEMOCUE GLUCOSE 201 ANALYZER IS MARKETED UNDER K020935. THE MALFUNCTION WAS CAUSED BY A BROKEN COPPER WIRE OR GLITCH AT THE PCB OF THE ANALYZER. THIS INCIDENT DID NOT OCCUR IN THE US.

    Description of Event or Problem · 1

    FIRST DIGIT IN DISPLAY DID NOT SHOW FOR BLOOD GLUCOSE METER HEMOCUE GLUCOSE 201+. RESULT 10.7 MMOL/L WAS WRONGLY SHOWN AS 0.7 MMOL/L. NO PT IMPACT WAS REPORTED BY THE CUSTOMER. THE DEVICE IS FOR PROFESSIONAL USE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCUE GLUCOSE 201+ ANALYZER GLUCOSE TEST SYSTEM LFR HEMOCUE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other