BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4502655 · Received February 6, 2015

    Report

    Report Number
    1052693-2015-00085
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 31, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 NOTED IN THE COMPLAINT: TEST STRIP ISSUE, USER HAD HIGH GLUCOSE VALUE. MFR ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (12/16/2014).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT OF BLOOD RESULT READING "HI". RECALL FROM MEMORY (FASTING AND NON-FASTING UNK). ON (B)(6) 2014 AT 12:03PM HI; (B)(6) 2014 AT 12:00PM HI; (B)(6) 2014 AT 10:00AM HI; (B)(6) 2014 AT 9:30AM 578MG/DL; (B)(6) 2014 AT 9:00AM HI. PHARMACIST PERFORMED A BLOOD TEST WITH THE CUSTOMER, "HI" RESULT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85965 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4257

    Patients

    Seq Age Sex Outcome Treatment
    1