BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK

    MDR report key: 4122533 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00349
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 24, 2014
    Report Date
    January 7, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAS HIGH GLUCOSE VALUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CALLER NORMALLY RANGES FROM 142-180MG/DL. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME IF THE CALL WERE "HI" AND "HI". LAST 5 RESULTS IN MEMORY WERE "HI", "HI", 223MG/DL, 200MG/DL, AND 230MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CALLER NORMALLY RANGES FROM 142-180 MG/DL. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME IF THE CALL WERE "HI" AND "HI". LAST 5 RESULT IN MEMORY WERE "HI", "HI", 223 MG/DL, 200 MG/DL, AND 230 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587519 SIDEKICK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. SIDEKICK SR4329

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR