BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4924413 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01199
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 22, 2015
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER'S TEST STRIP HAD POOR STORAGE.INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LO BLOOD GLUCOSE RESULT. EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 115 MG/DL. TESTING PERFORMED 14 TIMES DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY ON INSULIN PUMP TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/16/2018 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: 1:LO (B)(6) 2015 06:33PM. 2:28MG/DL (B)(6) 2015 06:12PM . 3:88MG/DL (B)(6) 2015 04:30PM. 4:47MG/DL (B)(6) 2015 10:50AM. 5:148MG/DL (B)(6) 2015 11:10PM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LO BLOOD GLUCOSE RESULT. EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 115 MG/DL. TESTING PERFORMED 14 TIMES DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY ON INSULIN PUMP TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPEC SINCE THEY ARE KEPT IN KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/16/2018 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: 1: LO, (B)(6) 2015, 06:33 PM; 2: 28 MG/DL, (B)(6) 2015, 06:12 PM; 3: 88 MG/DL, (B)(6) 2015, 04:30 PM; 4: 47 MG/DL, (B)(6) 2015, 10:50 AM; 5: 148 MG/DL, (B)(6) 2015, 11:10 PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463784 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2201

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR