BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2172397 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01774
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 30, 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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE US. THE COMPLAINT CANNOT BE VERIFIED DUE TO MISUSE OF THE PRODUCT. THE DISPLAY IS BROKEN DUE TO A MECHANICAL IMPACT. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISUSE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    PT REPORTED, THERE IS A BLACK SPOT ON THE DISPLAY. 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. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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