BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2943235 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00045
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 5, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN 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. THE DISPLAY WAS BROKEN DUE TO A MECHANICAL IMPACT. THE BROKEN DISPLAY COULD LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS. AS THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE OF 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 DISPLAY ON THE INFUSION DEVICE IS DAMAGED. PT STATED THE INSULIN VALUES IN THE DEVICE CAN BE MISINTERPRETED. NO FURTHER INFORMATION 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
    28980 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP