BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4792513 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00650
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 24, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 100-120 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BLOOD TEST PERFORMED WAS 119 MG/DL WITH (B)(6) METER AND 150 MG/DL WITH TRUERESULT METER. BLOOD TEST PERFORMED 25 MINUTES PRIOR USING TRUERESULT METER AND RESULT WAS 490 MG/DL. BACK TO BACK BLOOD TEST PERFORMED DURING CALL FASTING ((B)(6) 2015; 8:07PM) WITH RESULTS OF 89 MG/DL AND 93 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/21/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: MEMORY 1: 224MG/DL, (B)(6) 2015, 04:39PM; MEMORY 2: 151MG/DL, (B)(6) 2015, 03:17PM; MEMORY 3: 490MG/DL, (B)(6) 2015, 02:58PM; MEMORY 4: 94MG/DL, (B)(6) 2015, 09:25AM; MEMORY 5: 106MG/DL, (B)(6) 2015, 4:38PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280866 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RR4561

    Patients

    Seq Age Sex Outcome Treatment
    1