BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4844493 · Received June 11, 2015

    Report

    Report Number
    1052693-2015-00887
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 14, 2015
    Report Date
    December 16, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAD AN INACCURATE REFERENCE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 150MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 151 MG/DL AND 172 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS WEEK OF (B)(6) 2015. CUSTOMER INDICATES THAT SHE OBSERVED HER TEST RESULTS ARE 13 MG/DL. HIGHER THAN NORMAL RANGE AND 30 MG/DL LOWER WITHIN TWO HOURS AFTER MEAL. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (DATE/TIME NOT SET): 1:116MG/DL (B)(6) 2015 08:04AM. 2: 144MG/DL (B)(6) 2015 02:51PM. 3: 163MG/DL (B)(6) 2015 07:31AM. 4: 120MG/DL (B)(6) 2015 11:15PM. 5: 175MG/DL (B)(6) 2015 04:12PM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 150MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 151 MG/DL AND 172 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS WEEK OF (B)(6) 2015. CUSTOMER INDICATES THAT SHE OBSERVED HER TEST RESULTS ARE 13 MG/DL HIGHER THAN NORMAL RANGE AND 30 MG/DL LOWER WITHIN TWO HOURS AFTER MEAL. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (DATE / TIME NOT SET): (B)(6). ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381014 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2214

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR