BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2932123 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00056
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 28, 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
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE UP BUTTON DOES NOT OPERATE. THE CONNECTIONS OF THE UP FLEX PRINT ARE INTERRUPTED.

    Description of Event or Problem · 1

    PATIENT'S NURSE REPORTED HAVING CONCERNS WITH THE INFUSION DEVICE. NURSE STATED THE UP BUTTON ON THE INFUSION DEVICE IS NOT FUNCTIONAL. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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
    28540 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. 00700006862 NA

    Patients

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