BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2781865 · Received October 5, 2012

    Report

    Report Number
    2183996-2012-01353
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED ALL OF THE BUTTONS ON THE INFUSION DEVICE ARE NON-FUNCTIONAL. THE INFUSION DEVICE DISPLAYED AN E1 CARTRIDGE EMPTY ERROR, AND SHE WAS UNABLE TO CONFIRM THE ERROR MESSAGE BY PRESSING THE CHECK BUTTON. SHE CHANGED THE BATTERY, BUT THIS DID NOT RESOLVE THE ISSUE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR INSULIN INFUSION PUMP| ACCESSORIES| INSULIN