BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2841982 · Received November 14, 2012

    Report

    Report Number
    2183996-2012-01742
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    August 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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'S SISTER REPORTED THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. THE PT WAS HOSPITALIZED 3 MONTHS AGO DUE TO CRAMPS, AND THE PT'S BLOOD GLUCOSE SUDDENLY ELEVATED TO 1200 MG/DL. THE PT IS NOW AT HOME AND USES A PEN FOR INSULIN DELIVERY. NO FURTHER INFO WAS AVAILABLE, AND ADDITIONAL ATTEMPTS TO REACH THE PT WERE UNSUCCESSFUL. THE INFUSION DEVICE WAS REQUESTED 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 Hospitalization INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES