BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO TRUETEST GLUCOSE METER

    MDR report key: 4652292 · Received March 27, 2015

    Report

    Report Number
    MW5041793
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    January 21, 2015
    Report Date
    March 27, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTS THAT THE MACHINE WAS GIVING AN "ERROR" AFTER DRAWING BLOOD INTO THE TEST STRIP CAPILLARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205328 NIPRO TRUETEST GLUCOSE METER NIPRO TRUETEST GLUCOSE METER NBW NIPRO DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention LANTUS 10 MG QHS| METOPROLOL X1 50 MG QD| LISINOPRIL 10 MG QD| METFORMIN 500 MG BID