BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK

    MDR report key: 4122462 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00347
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 23, 2014
    Report Date
    December 17, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE OR USER HAD AN INACCURATE REFERENCE OR USER HAD INCORRECT CODE KEY.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CALLER NORMALLY RANGES FROM 100-115MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (192) AND THE LOWEST NORMAL RESULT (100) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CALLER NORMALLY RANGES FROM 100-115 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (192) AND THE LOWEST NORMAL RESULT (100) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587797 SIDEKICK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. SIDEKICK SR4417

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR