BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IACCU-CHEK SPIRIT

    MDR report key: 1851263 · Received September 23, 2010

    Report

    Report Number
    2183996-2010-01968
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 13, 2010
    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. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT RECEIVED A2 LOW BATTERY ALERT ON (B)(6) 2010 AT 9:00 P.M. PATIENT "DISCARDED THE PUMP" IN RUN MODE. PATIENT ATTEMPTED TO RESTART INFUSION DEVICE ON (B)(6) 2010 AT 12:00 A.M. THE INFUSION DEVICE HAD NO FUNCTION. PATIENT CHANGED THE BATTERY AND THE INFUSION DEVICE STILL HAD NO FUNCTION. PATIENT DID NOT RECEIVE THE E2 BATTERY DEPLETED OR E7 ELECTRONIC ERROR. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. PATIENT BELIEVED HE MIGHT HAVE "BUMPED" THE INFUSION DEVICE. THERE WERE NO ABNORMAL NOISES. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET