BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982065 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00187
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. E8 (POWER INTERRUPT) WAS FOUND IN THE HISTORY LIST. THE SOFT COMPONENT OF THE DOWN BUTTON IS DAMAGED DUE TO HANDLING WITH SHARP OBJECTS. THE BUTTON SHOULDN'T BE ACTUATED BY USING HARD OR SHARP OBJECTS. THE SOFT COMPONENTS OF THE DOWN BUTTON ARE LEAKY AS A RESULT LIQUID ENTERED THE PUMP. DUE TO THIS AND THE ALWAYS ACTIVATED DOWN BUTTON THE PUMP TRIGGERED AN UNCLEAR ABLE E8 ERROR MESSAGE. THE CHECK BUTTON PASSED THE OPTICAL AND FUNCTIONAL INVESTIGATION SUCCESSFUL AND MEETS THE SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    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

    PT REPORTED THE CHECK BUTTONS ON THE INFUSION DEVICE IS NOT RESPONDING. PT STATED HE HAS EXPERIENCED NO HEALTH CONCERNS. 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 EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55374 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES