BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4924480 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01140
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 17, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT UNDER EVALUATION.

    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 HIGH BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 130 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN VEHICLE AND KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/24/2018 AND OPEN VIAL DATE IS WEEK OF (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:306MG/DL (B)(6) 2015 12:30PM. 2:437MG/DL (B)(6) 2015 11:43PM. 3:175MG/DL (B)(6) 2015 07:43AM . 4:160MG/DL (B)(6) 2015 06:26PM . 5:146MG/DL (B)(6) 2015 12:28PM . 6:192MG/DL (B)(6) 2015 07:52PM . 7:176MG/DL (B)(6) 2015 06:43PM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 130 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN VEHICLE AND KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/24/2018 AND OPEN VIAL DATE IS WEEK OF (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 306MG/DL, (B)(6) 2015, 12:30PM; 437MG/DL, (B)(6) 2015, 11:43PM; 175MG/DL, (B)(6) 2015, 07:43AM; 160MG/DL, (B)(6) 2015, 06:26PM; 146MG/DL, (B)(6) 2015, 12:28PM; 192MG/DL, (B)(6) 2015, 07:52PM; 176MG/DL, (B)(6) 2015, 06:43PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463936 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2256

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR