BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5033584 · Received August 26, 2015

    Report

    Report Number
    1052693-2015-01515
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 26, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET EVAULATED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE TEST RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015 AS A RESULT OF THE METER'S READINGS. CURRENTLY NOT TAKING INSULIN, BUT INSTEAD IS TAKING MEDICATION TO MANAGE DIABETES. CUSTOMERS A1C WAS 7.6 AT LAST DOCTOR'S VISIT IN (B)(6) 2015. BACK TO BACK BLOOD TEST PERFORMED NON-FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 101 MG/DL AND 109 MG/DL. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/28/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1: 98MG/DL (B)(6) 2015 07:29:00 AM FASTING:YES; 2: 263MG/DL (B)(6) 2015 07:29:00 AM FASTING:YES; 3: 92MG/DL (B)(6) 2015 07:53:00 AM FASTING:YES; 4: 97MG/DL (B)(6) 2015 07:51:00 AM FASTING:YES; 5: 119MG/DL (B)(6) 2015 07:28:00 PM FASTING:YES. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563450 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1633

    Patients

    Seq Age Sex Outcome Treatment
    1