BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4762633 · Received May 7, 2015

    Report

    Report Number
    1052693-2015-00685
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 7, 2015
    Manufacturer
    NIPRO DIAGNOSTICS INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM IN THE LOW 100 MG/DL. TESTING PERFORMED ONCE DAILY. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED DURING CALL FASTING ((B)(6) 2015; 5:50 PM) WITH RESULTS OF 156 MG/DL AND 529 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/25/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (DATE / TIME NOT SET CORRECTLY): 159 MG/DL (B)(6) 2015 03:30 PM; 179 MG/DL (B)(6) 2015 11:52 PM; 120 MG/DL (B)(6) 2015 11:51 PM; 173 MG/DL (B)(6) 2015 11:53 PM; 132 MG/DL (B)(6) 2015 11:51 PM; 159 MG/DL (B)(6) 2015 11:59 PM; 403 MG/DL (B)(6) 2015 11:55 PM; 131 MG/DL (B)(6) 2015 11:53 PM; 193 MG/DL (B)(6) 2015 11:52 PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299863 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS INC. TRUETRACK RR4402

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization