BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5025805 · Received August 24, 2015

    Report

    Report Number
    1052693-2015-01500
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    July 24, 2015
    Report Date
    October 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD POOR STORAGE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE TEST RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 170 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 TAKING MEDICATION TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/14/2018 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:361MG/DL (B)(6) 2015 03:24 PM; 2:244MG/DL (B)(6) 2015 03:43 PM; 3:191MG/DL (B)(6) 2015 06:27 PM; 4:273MG/DL (B)(6) 2015 03:37 PM; 5:177MG/DL (B)(6) 2015 10:13 AM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE TEST RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 170 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 TAKING MEDICATION TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/14/2018 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:361MG/DL (B)(6) 2015 03:24 PM. 2:244MG/DL (B)(6) 2015 03:43 PM. 3:191MG/DL (B)(6) 2015 06:27 PM. 4:273MG/DL (B)(6) 2015 03:37 PM. 5:177MG/DL (B)(6) 2015 10:13 AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558183 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2278

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR