BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2943268 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00027
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 2, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    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.

    Additional Manufacturer Narrative · 1

    E6 AND E8 WERE FOUND IN THE HISTORY LIST. THE PUMP CORRECTLY TRIGGERED THE E6 ERROR MESSAGES DUE TO TEMPORARY STEP LOSS. THIS CAN BE CAUSED BY TOO HIGH FRICTION. THE PUMP CORRECTLY TRIGGERED AN E8 ERROR AS A RESULT OF THE POWER INTERRUPT WHILE THE PUMP WAS IN RUN MODE.

    Description of Event or Problem · 1

    PT REPORTED THE SIDE BUTTONS ON THE INFUSION DEVICE OFTEN DO NOT FUNCTION. PT STATED THE DEVICE IS ALSO RECEIVING AN E8 (MECHANICAL ERROR) MESSAGE AND AN E8 (POWER INTERRUPT) ERROR MESSAGE. NO FURTHER INFO IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29121 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES