BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE TRACK

    MDR report key: 4894440 · Received July 1, 2015

    Report

    Report Number
    1052693-2015-01011
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 25, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED BLOOD GLUCOSE TEST RESULT RANGE AFTER MEAL IS 145 MG/DL. TESTING PERFORMED FOUR TIMES DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING INSULIN TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 250 MG/DL AND 222 MG/DL. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPEC SINCE THEY ARE KEPT IN CUSTOMER'S PURSE. TEST STRIPS LOT MFR'S EXPIRATION DATE IS 01/22/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: 247MG/DL (B)(6) 2015 02:23PM; 230MG/DL (B)(6) 2015 03:48PM; 552MG/DL (B)(6) 2015 03:49PM; 350MG/DL (B)(6) 2015 03:48PM; 357MG/DL (B)(6) 2015 03:23PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429578 TRUE TRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUE RESULT RR4484

    Patients

    Seq Age Sex Outcome Treatment
    1