BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2800123 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01547
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 26, 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. 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 REPORTED THE VIBRATION ALARM ON THE INFUSION DEVICE IS DEFECTIVE. ON (B)(6) 2012 AT APPROXIMATELY 11:00 P.M., THE INFUSION DEVICE DISPLAYED AN E7 ELECTRONIC ERROR. HE CHANGED THE BATTERY BUT WAS UNABLE TO RESOLVE THE ERROR MESSAGE. HE CHANGED THE BATTERY AGAIN AROUND 12:00 A.M. THE ERROR MESSAGE CLEARED BUT THE VIBRATION ALARM DID NOT FUNCTION CORRECTLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    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 DATE OF THERAPY: UNK| INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES