BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODOT BLOOD GLUCOSE TEST STRIP

    MDR report key: 6972100 · Received October 24, 2017

    Report

    Report Number
    MW5072918
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    October 21, 2017
    Report Date
    October 21, 2017
    Manufacturer
    CAMBRIDGE SENSORS LIMITED
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE ON A CALL (LUCKILY NOT A DIABETIC CALL) I NOTICED THAT THE GLUCOMETER DOES NOT FUNCTION CORRECTLY. I INSERTED THE TEST STRIP AS I DO EVERY OTHER TIME, THE MACHINE RECOGNIZED THERE WAS A STRIP INSERTED AND IT POWERED ON LIKE NORMAL, HOWEVER, WHEN I PLACED A BLOOD SAMPLE ON THE TEST STRIP, THE MACHINE DID NOT REGISTER THAT THERE WAS A SAMPLE PRESENT, I INSERTED A NEW TEST STRIP AND TRIED AGAIN, ONLY TO GET THE SAME OUTCOME. THIS IS ONE OF MULTIPLE REPORTS RECEIVED OF THIS LOT OF TEST STRIPS FAILING TO DRAW SUFFICIENT SAMPLES INTO THE UNIT, REQUIRING USE OF 2-5 STIRPS TO OBTAIN A SAMPLE AND READING. OTHER LOTS ARE FUNCTIONING AS INTENDED. HORIZON MEDICAL PRODUCTS. DIAGNOSIS OR REASON FOR USE: CHECKING FINGERSTICK BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754250 MICRODOT BLOOD GLUCOSE TEST STRIP GLUCOSE TEST STRIPS NBW CAMBRIDGE SENSORS LIMITED 6120501

    Patients

    Seq Age Sex Outcome Treatment
    1