BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4528086 · Received February 12, 2015

    Report

    Report Number
    1052693-2015-00104
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    January 4, 2015
    Report Date
    February 12, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    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. 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 ABOUT HIGH BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE RESULTS RANGES FROM 85 TO 100 MG/DL. BACK TO BACK BLOOD TEST PERFORMED TWO HOURS AFTER MEAL ((B)(6) 2015; 7:28PM) WITH RESULTS OF 257 MG/DL AND 229 MG/DL. VERIFIED STORAGE OF TEST STRIPS AND CONTROL SOLUTION IS WITHIN SPECIFICATION AND THEY ARE KEPT INSIDE THE BED ROOM DRAWER. RECALL TEST RESULTS FROM METER MEMORY (DATE/TIME NOT CORRECTLY SET): (B)(6) 2014, 10:42PM - 368MG/DL (1.5 HOURS AFTER MEAL); (B)(6) 2014, 10:41PM - 349MG/DL (1.5 HOURS AFTER MEAL); (B)(6) 2014, 2:24PM - 112MG/DL; (B)(6) 2014, 1:56AM - 133MG/DL; (B)(6) 2014, 10:19PM - 245 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103415 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR2054

    Patients

    Seq Age Sex Outcome Treatment
    1