BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4795194 · Received May 21, 2015

    Report

    Report Number
    1052693-2015-00758
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    April 23, 2015
    Report Date
    May 20, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED FOR EVAL: NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: USER'S TEST STRIP HAD POOR STORAGE, USER'S MISUNDERSTANDING OF ERRATIC RESULTS.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OR ERRATIC BLOOD RESULTS VIA FIANCE, ERICA. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPEC SINCE THEY ARE KEPT IN BEDROOM. TEST STRIP LOT MFR'S EXPIRATION DATE IS 12/31/2015 AND OPEN VIAL DATE IS SEPTEMBER 2014. RECALLED TEST RESULTS FROM METER MEMORY WERE PERFORMED NON-FASTING: 157 MG/DL, (B)(6) 2015, 12:01 PM; 157 MG/DL, (B)(6) 2015, 08:22 AM; 88 MG/DL, (B)(6) 2015, 08:20 AM; 83 MG/DL, (B)(6) 250158, 06:44 PM; 193 MG/DL, (B)(6) 2015, 10:18 PM; NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333784 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC TRUETRACK RR4475

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization