BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4494575 · Received February 5, 2015

    Report

    Report Number
    1052693-2015-00069
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    December 23, 2014
    Report Date
    January 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION DESCRIBED IN THE COMPLAINT: USER HAD AN INACCURATE REFERENCE. MFR ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (12/23/2014).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. NORMAL RANGES FROM 98 -160 MG/DL; FASTING AND BEFORE/AFTER MEALS. BACK TO BACK BLOOD TEST DECLINED. VERIFIED PROPER STORAGE OF TEST STRIPS. CONSUMER COMPLAINT THAT METER RESULTS ARE HIGHER COMPARED TO NOVAMAX LINK METER RESULTS ARE HIGHER COMPARED TO NOVAMAX LINK METER. RECALL TEST RESULTS FROM METER MEMORY: ON (B)(6) 2014; 2:21PM - 152MG/DL; (B)(6) 2014; 12:42AM - 342MG/DL; (B)(6) 2014; 12:40AM - 439MG/DL; (B)(6) 2014; 12:42AM - 148MG/DL; (B)(6) 2014; 1:54PM - 164MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85582 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4469

    Patients

    Seq Age Sex Outcome Treatment
    1