BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5014797 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01404
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 16, 2015
    Report Date
    December 4, 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

    (B)(4). PRODUCT UNDER EVAL.

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION IMPROPER STORAGE OF TEST STRIPS AS INDICATED BY CUSTOMER. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD GLUCOSE TEST RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 145 MG/DL. TESTING PERFORMED ONCE DAILY IN THE MORNING FASTING. 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 MEDICATION TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MFR'S EXPIRATION DATE IS 09/17/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: LO (B)(6) 2015 09:04AM; LO (B)(6) 2015 09:02AM; 157MG/DL (B)(6) 2015 08:49AM; 155MG/DL (B)(6) 2015 08:48AM; 142MG/DL (B)(6) 2015 09:25AM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD GLUCOSE TEST RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 145 MG/DL. TESTING PERFORMED ONCE DAILY IN THE MORNING FASTING. 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 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 09/17/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:LO (B)(6) 2015 09:04AM. 2:LO (B)(6) 2015 09:02AM. 3:157MG/DL (B)(6) 2015 08:49AM. 4:155MG/DL (B)(6) 2015 08:48AM. 5:142MG/DL (B)(6) 2015 09:25AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535437 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1580

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR