BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2913478 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02032
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 12, 2012
    Report Date
    March 21, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    Additional Manufacturer Narrative · 1

    THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND DESTROYED THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON IS PERMANENT ACTIVE DUE TO AN EXTERNAL MECHANIC DAMAGE.

    Description of Event or Problem · 1

    PT REPORTED THE PROTECTIVE RUBBER ON THE LATERAL BUTTONS IS "USED UP," AND THE INFUSION DEVICE TURNED OFF UNEXPECTEDLY WITHOUT PROVIDING AN ALERT/ERROR ON (B)(6) 2012. SHE REINSERTED THE BATTERY, AND THE INFUSION DEVICE APPEARED TO WORK CORRECTLY. ON (B)(6) 2012, NONE OF THE BUTTONS ON THE INFUSION DEVICE WOULD RESPOND. SHE REINSERTED THE BATTERY AGAIN, BUT THIS DID NOT RESOLVE THE CONCERN. THE INFUSION DEVICE WAS NOT DROPPED OR BEEN EXPOSED TO WATER OR OTHER INTERFERING FACTORS. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTMS INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN