BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4908461 · Received July 9, 2015

    Report

    Report Number
    1052693-2015-01091
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 13, 2015
    Report Date
    December 14, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAS HIGH GLUCOSE VALUE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4) . PRODUCT RETURNED ON (B)(6) 2015, BUT EVALUATION IN-PROCESS.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HI BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 250 TO 300 MG/DL. TESTING PERFORMED THREE TIMES DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY TAKING INSULIN TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED NON-FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF HI AND 509 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: 1:HI ON (B)(6) 2015 03:30PM; 2:509MG/DL ON (B)(6) 2015 03:40PM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HI BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 250 TO 300 MG/DL. TESTING PERFORMED THREE TIMES DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY TAKING INSULIN TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED NON-FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF HI AND 509 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: HIGH, (B)(6) 2015, 03:30PM; 509MG/DL, (B)(6) 2015, 03:40PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445461 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2317

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR