BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4534482 · Received February 17, 2015

    Report

    Report Number
    1052693-2015-00157
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    January 22, 2015
    Report Date
    February 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: STRIP ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "HI" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS IS OVER 300 MG/DL. TESTING PERFORMED (ONCE /TWICE/THREE TIMES) DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING INSULIN TO MANAGE DIABETES AND STEROIDS. BLOOD TEST PERFORMED DURING CALL ((B)(6) 2015) WITH RESULTS OF "HI" (FASTING / BEFORE MEAL/ AFTER MEAL). STORAGE OF TEST STRIPS IS WITHIN SPECIFICATION NOT VERIFIED. TEST STRIP LOT MFR'S EXPIRATION DATE IS 03/16/2017 AND OPEN VIAL DATE IS NOT VERIFIED. RECALL TEST RESULTS PERFORMED (FASTING/ BEFORE MEALS/ AFTER MEALS) FROM METER MEMORY: (B)(6); 8:47PM - HI; (B)(6); 8:37PM - HI; (B)(6); 8:36PM - HI; (B)(6); 8:35PM - HI; (B)(6); 12:35PM - 309 MG/DL; (B)(6); 10:41AM - 326 MG/DL. BASED ON THE "HI" RESULTS SEEN IN THE MEMORY AND OBTAINED BY THE CUSTOMER, THE COMPLAINT IS REPORTABLE. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113505 TRUETRACK BLOOD GLUCOSE CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RR4523

    Patients

    Seq Age Sex Outcome Treatment
    1