BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK

    MDR report key: 4792541 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00439
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 28, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI." CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 200MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/30/2017. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN IN USE FOR MORE THAN 4 MONTHS AND THAT THE TEST STRIPS HAVE BEEN STORED IN HER BEDROOM. REVIEWED METER MEMORY: HI MG/DL, (B)(6) 2015, 07:12:36 PM, FASTING: NO; 231MG/DL, (B)(6) 2015, 07:12:36 PM, FASTING: NO; 285MG/DL,(B)(6) 2015, 07:12:36 PM, FASTING: NO; 586MG/DL, (B)(6) 2015, 07:12:36 PM, FASTING: NO; 519MG/DL, (B)(6) 2015, 07:12:36 PM, FASTING: NO. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280511 SIDEKICK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. SIDEKICK SR4555

    Patients

    Seq Age Sex Outcome Treatment
    1