BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1911393 · Received November 24, 2010

    Report

    Report Number
    2183996-2010-02489
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    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
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED, THE INFUSION DEVICE HAD AN INTERRUPT IN POWER WHILE IN USE. PT STATED NOTICED, THE INFUSION DEVICE SCREEN WAS BLANK, BUT WHEN PRESSED A BUTTON NOTHING CAME ON. PT WAS UNSURE OF HOW LONG THIS HAD BEEN OCCURRING, BUT HAD RISING BLOOD GLUCOSE LEVELS. PT WAS UNABLE TO COMMENT ON WHAT THE BLOOD GLUCOSE LEVEL WAS. PT REPORTED REMOVING THE BATTERY FOR 5 MINUTES, PLACED IT BACK INTO THE INFUSION DEVICE AND EVERYTHING WAS WORKING AS INTENDED. PT STATED EVENT OCCURRED 5-6 DAYS AGO AND HAS CHANGED THE BATTERY AND BATTERY COVER SINCE THE EVENT. PT REPORTED, THERE WAS NO ALARM PRIOR TO THE INFUSION DEVICE SHUTTING OFF. HAD PT CHECK HISTORY ALARM; THERE WAS NO ALERT OR ALARM FOR BATTERY LOW OR BATTERY DEPLETED. NO FURTHER INFORMATION IS AVAILABLE. 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 PRODUCT FOR EVALUATION.

    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 Required Intervention INSULIN| INSULIN INFUSION SET