BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4528104 · Received February 12, 2015

    Report

    Report Number
    1052693-2015-00103
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    January 4, 2015
    Report Date
    February 5, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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: USER HAD INACCURATE REFERENCE, USER REUSED TEST STRIP OR USER'S TEST STRIP HAD POOR FILL. MANUFACTURER ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (01/04/2015).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE RESULTS RANGE FROM 90 TO 110 MG/DL. BACK TO BACK BLOOD TEST PERFORMED (01/04/2015; 5:22PM) WITH RESULTS OF 155MG/DL AND 149 MG/DL (NOT VERIFIED IF BEFORE OR AFTER MEAL). VERIFIED STORAGE OF TESTS STRIPS IS WITHIN SPECIFICATION AND THEY ARE KEPT IN THE LIVING ROOM. RECALL FASTING TEST RESULTS FROM METER MEMORY: (B)(6) 2014, 10:27AM - 109MG/DL; (B)(6) 2014; 10:25AM - 112MG/DL; (B)(6) 2014, 7:09AM - 129MG/DL; (B)(6) 2014, 10:17AM - 226MG/DL; (B)(6) 2014, 10:16AM - 43MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103432 TRUERESULT BLOOD GLUCSOE SYSETM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR1910

    Patients

    Seq Age Sex Outcome Treatment
    1