BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2012087 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00394
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    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
    UNKNOWN

    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

    THE PT REPORTED ISSUES WITH THE BLUETOOTH CONNECTION BETWEEN THE INFUSION DEVICE AND BLOOD GLUCOSE MONITOR. THE PT THEN FOUND THE INFUSION DEVICE HAD SHUT DOWN WITHOUT DISPLAYING AN ALERT/ERROR MESSAGE. THE PT CHANGED THE BATTERY 3 TIMES AND WAS ABLE TO RESTART THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET