BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4688780 · Received April 9, 2015

    Report

    Report Number
    1052693-2015-00403
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 13, 2015
    Report Date
    April 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NOT FASTING RANGE FROM 130 TO 160 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED DURING CALL FASTING ((B)(6) 2015; 11:51PM) WITH RESULTS OF 523 MG/DL AND 483 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN SPECIFICATION SINCE THEY ARE KEPT IN BEDROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/30/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NOT FASTING FROM METER MEMORY: 421MG/DL (B)(6) 2015, 11:41:18 PM; 421MG/DL (B)(6) 2015, 11:49:18; 403MG/DL, (B)(6) 2015 11:35:18 PM; 435MG/DL (B)(6) 2015, 08:48:18 PM; 317MG/DL, (B)(6) 2015, 05:05:18 PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233395 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4531

    Patients

    Seq Age Sex Outcome Treatment
    1