BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4924422 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01207
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 16, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 TO 270 MG/DL. CUSTOMER SYMPTOMS AND MEDICAL HEALTH STATUS NOT DISCLOSED. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. STORAGE OF PRODUCT NOT VERIFIED. TEST STRIP LOT MFR'S EXPIRATION DATE IS (B)(6) 2016 AND OPEN VIAL DATE IS NOT VERIFIED. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: 282MG/DL (B)(6) 2015 04:00PM; 289MG/DL (B)(6) 2015 02:00PM; 302MG/DL (B)(6) 2015 08:10AM; 110MG/DL (B)(6) 2015 11:16AM; 243MG/DL (B)(6) 2015 08:00AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463646 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RP4233

    Patients

    Seq Age Sex Outcome Treatment
    1