BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4548125 · Received February 19, 2015

    Report

    Report Number
    1052693-2015-00174
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 24, 2015
    Report Date
    February 19, 2015
    Manufacturer
    NIPRO DIAGNOSTICS INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT #: (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI." EXPECTED GLUCOSE RANGE IS USUALLY BETWEEN 150 AND 200 MG/DL FASTING. RECALLED THE LAST 5 BLOOD RESULTS IN METER MEMORY: (B)(6), 6:15 HI; (B)(6), 6:09 PM HI; (B)(6), 6:06 PM HI; (B)(6), 5:59 PM HI; (B)(6), 5:53 PM HI. VERIFIED THE STRIPS WERE OPENED TWO WEEKS AGO. THE STRIPS EXPIRE 04/23/2017. CUSTOMER STORES THE STRIPS/METER INSIDE CARRYING CASE IN THE KITCHEN. THE CUSTOMER IS FEELING FINE NO MEDICAL ATTENTION NEEDED. I CONFIRMED THAT CUSTOMER HAS CONTROL SOLUTION THAT HAS BEEN IN USE FOR MORE THAN 3 MONTHS (4ACLB64). CUSTOMER RAN BACK TO BLOOD TEST: HI AND HI WITHIN TWO HOURS OF A MEAL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119456 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS INC. TRUERESULT PR1935

    Patients

    Seq Age Sex Outcome Treatment
    1