BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4494576 · Received February 5, 2015

    Report

    Report Number
    1052693-2015-00067
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER RE-USED TEST STRIP, USER'S TEST STRIP HAD POOR FILL. MFR ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (12/30/2014).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. NORMAL RESULTS RANGE FROM 110-130 MG/DL FASTING. BACK TO BACK BLOOD TEST PERFORMED ((B)(6) 2014; 6:39PM) - RESULTS: 178 MG/DL AND 121 MG/DL; CONSUMER JUT ATE DINNER ABOUT 10 MINUTES AGO. TEST STRIPS ARE STORED IN ORIGINAL VIAL INSIDE THE METER CASE IN DINING ROOM. RECALL TEST RESULTS (B)(6) 2014; 11:15AM - 56 MG/DL; (B)(6) 2014; 11:20AM - 84 MG/DL; (B)(6) 2014; 11:40AM - 39 MG/DL; (B)(6) 2014; 11:31AM - 165 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84870 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1726

    Patients

    Seq Age Sex Outcome Treatment
    1