BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2833332 · Received October 26, 2012

    Report

    Report Number
    2183996-2012-01660
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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 WHEN SHE PROGRAMS A BOLUS, THE INFUSION DEVICE SHUTS DOWN AND RESTARTS. PT STATED SHE HAS ALREADY TRIED CHANGING THE BATTERIES BUT THE CONCERN PERSISTS. PT REPORTED THAT NO ERROR MESSAGE APPEARS ON THE DISPLAY OF THE INFUSION DEVICE AND THAT THIS CONCERN OCCURS DURING THE WHOLE BOLUS PROGRAMMING PROCEDURES AND ALSO SOME TIMES DURING THE WHOLE BOLUS PRIMING. PT IS CURRENTLY ON HER BACKUP INFUSION DEVICE. 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 LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES