BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2191268 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02121
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 21, 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
    AS
    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

    FATHER REPORTED THE INFUSION DEVICE DISPLAYED E7 ELECTRONIC ERROR WHILE IN THE RUN MODE. FATHER CHANGED THE BATTERY SEVERAL TIMES, AND THE INFUSION DEVICE COMPLETED THE SELF-TEST AND RETURNED TO THE STOP MODE. THE INFUSION DEVICE FAILED TO VIBRATE DURING THE SELF-TEST. AS SOON AS THE INFUSION DEVICE WAS PLACED IN RUN MODE, THE E7 ELECTRONIC ERROR REAPPEARED. CORRECT TYPE OF BATTERY IS USED IN THE INFUSION DEVICE. FATHER REPORTED THE LAST TIME THE INFUSION DEVICE FAILED TO VIBRATE DURING THE SELF-TEST, THE BATTERY WAS CHANGED AND IT STARTED VIBRATING AGAIN. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER, MOISTURE, OR INSULIN INGRESS. INFUSION DEVICE WAS NOT EXPOSED TO EXTREME TEMP CHANGES OR ELECTROMAGNETIC FIELDS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADD'L 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 INSULIN| INSULIN INFUSION SET