BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2913485 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02049
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 16, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT REPORTED THAT HER INFUSION DEVICE DISPLAYED E2 (BATTERY DEPLETED) WITHOUT FIRST DISPLAYING A2 (BATTERY LOW). THE LAST TIME THIS OCCURRED WAS AROUND THANKSGIVING DAY AND IT HAS ONLY HAPPENED TWICE. THE PT CHECKED THE HISTORY IN THE DEVICE AND THERE IS NO A2 MESSAGE. THE PT WILL SWITCH 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. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP