BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK

    MDR report key: 4494573 · Received February 5, 2015

    Report

    Report Number
    1052693-2015-00073
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 27, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: STRIP ISSUE, USER HAS HIGH GLUCOSE VALUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". THE CUSTOMER STATES THE STRIPS ARE WITHIN THE EXPIRATION DATE (01/25/2017) AND AR STORED CORRECTLY. PERFORMED A BLOOD TEST RESULT; 594MG/DL (TOO INSULIN ABOUT 5 MINUTES AGO) LAST 5 RESULTS IN MEMORY: R-25 HI ON (B)64) AT 9:15AM (FASTING), R-24 387, R-23 461, R-22 HI, R-21 105. THE CUSTOMER STATES THE RESULTS IN THE MEMORY ARE ALL FASTING. NO ADVISER EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84820 SIDEKICK BLOOD GLUCOSE SYSETM NBW NIPRO DIAGNOSTICS, INC SIDEKICK SR4486

    Patients

    Seq Age Sex Outcome Treatment
    1