BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3202083 · Received June 27, 2013

    Report

    Report Number
    1033800-2013-00115
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 27, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. PER THE CALLER, RESULTS IN MEMORY WERE (B)(6) 11:40A 260MG/DL, (B)(6) 11:33A 215, (B)(6) 11:28A LO, (B)(6) 4:30P 187 MG/DL. CUSTOMER WAS NOT SURE IF HE USED THE SAME FINGER FOR THE LO READING AND THE 215 MG/DL READING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293199 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC TRUERESULT PP1220

    Patients

    Seq Age Sex Outcome Treatment
    1