BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO CARTRIDGE

    MDR report key: 2915377 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02061
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 14, 2012
    Report Date
    March 11, 2013
    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
    GM
    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 THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE BUTTONS PASSED THE OPTICAL AND FUNCTIONAL INVESTIGATION SUCCESSFULLY. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    Description of Event or Problem · 1

    PT REPORTED THE OK BUTTON ON THE INFUSION DEVICE DOESN'T WORK. PT REPORTED EXPERIENCING NO HEALTH PROBLEMS. NO FURTHER INFO IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE 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
    1 ACCU-CHEK SPIRIT COMBO CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES