BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2800102 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01588
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE INFUSION DEVICE SHUTS DOWN BY ITSELF WITH NO WARNING. ON (B)(6) 2012 AT 11:26 AM W1 WAS DISPLAYED AND AT 1:00PM E8 (POWER INTERRUPT) WAS DISPLAYED. HER BLOOD GLUCOSE MEASURED 250 MG/DL. SHE ATTEMPTED TO BOLUS AND THE INFUSION DEVICE SHUT DOWN WITH NO WARNING. SHE REMOVED AND REINSERTED THE BATTERY AND THE INFUSION DEVICE RESTARTED. SHE BOLUSED 6-7 UNITS OF INSULIN AND AT 3:30PM HER BLOOD GLUCOSE MEASURED 150 MG/DL. THE PT CURRENTLY HAS THE FLU. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED 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 21 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES