BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2190595 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02108
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    February 1, 2011
    Report Date
    July 18, 2011
    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
    UNKNOWN

    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 THE VIBRATION ALARM OF THE INFUSION DEVICE HAS BEEN DEFECTIVE SINCE (B)(6) 2011. ON THE DAY OF THE REPORT, THE INFUSION DEVICE DISPLAYED E1 CARTRIDGE EMPTY AND E2 BATTERY DEPLETED ERRORS. PT CHANGED THE BATTERY, AND THEN THE INFUSION DEVICE DISPLAYED AN E7 ELECTRONIC ERROR. HE CHANGED THE BATTERY AGAIN, BUT THIS DID NOT RESOLVE THE ERROR MESSAGE. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS OR DROPPED ON THE FLOOR. THERE WERE NO UNUSUAL NOISES. THE CORRECT TYPE OF BATTERY WAS USED IN THE INFUSION DEVICE, AND THE BATTERY SETTING WAS PROGRAMMED CORRECTLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR INSULIN INFUSION SET| INSULIN