BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2850142 · Received November 21, 2012

    Report

    Report Number
    2183996-2012-01792
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 20, 2012
    Report Date
    November 10, 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 A FEW WEEKS AGO, THE INFUSION DEVICE STOPPED WORKING BY ITSELF IN THE NIGHT. PT REPORTED EXPERIENCING NO HEALTH PROBLEMS. PT REPORTED THE DATES IN THE HISTORY WERE ALSO BLANK. PT STATED THE INFUSION DEVICE WORKS CORRECTLY AT THE MOMENT. NO FURTHER INFO IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.

    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 29 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES