BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3884660 · Received June 19, 2014

    Report

    Report Number
    1823260-2014-04481
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 9, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE AND THIS CAUSED HYPERGLYCEMIA OF APPROXIMATELY 300 MG/DL. HE DISCONNECTED THE INFUSION SET AND DELIVERED A BOLUS, AND NO INSULIN WAS DELIVERED FROM THE TUBE. HE REPORTED THIS IS AN INTERMITTENT ISSUE. HIS NORMAL BLOOD GLUCOSE IS 100-120 MG/DL, AND HE SWITCHED TO HIS BACKUP INFUSION DEVICE TO LOWER HIS BLOOD GLUCOSE. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCTS WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361547 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1