BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1030787 · Received April 17, 2008

    Report

    Report Number
    2183996-2008-00480
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    November 1, 2007
    Report Date
    April 2, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE HAS HAD 10 POWER INTERRUPTIONS ON HER INFUSION DEVICE OVER THE PAST 4-5 MONTHS. SHE STATED THAT WHEN THE ISSUE BEGAN, IT WAS ONLY DURING BOLUS DELIVERY AND NOW IT IS OCCURRING DURING BASAL DELIVERY. SHE STATED THAT THE INFUSION DEVICE SHUTS DOWN AND WILL POWER ON AGAIN WITH AN E8 (POWER INTERRUPT) ERROR. SHE STATED THAT SHE HAS CHANGED THE BATTERY AND BATTERY COVER, BUT THE ISSUE HAS PROGRESSIVELY GOTTEN WORSE. SHE SWITCHED TO HER BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET