BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2781863 · Received October 5, 2012

    Report

    Report Number
    2183996-2012-01501
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 27, 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
    AU
    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

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT'S MOTHER THINKS THE INFUSION DEVICE HAS BEEN DELIVERING TOO HIGH AN AMOUNT OF INSULIN FOR 1.5 WEEKS. THE PT'S BLOOD GLUCOSE LEVEL HAS BEEN AS LOW AS 60 MG/DL. THE PT'S MOTHER ALSO HAS CONCERNS ABOUT THE E4 (OCCLUSION ERROR) MESSAGE THAT IS SOMETIMES DISPLAYED ON THE INFUSION DEVICE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSION OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED 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 4 YR INSULIN| ACCESSORIES| INSULIN INFUSION PUMP