BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3030433 · Received April 2, 2013

    Report

    Report Number
    2183996-2013-00560
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE SOFT COMPONENT OF THE UP BUTTON IS DAMAGED AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. DUE TO THE LEAKY SOFT COMPONENT, LIQUID ENTERED THE PUMP AND DESTROYED THE FUNCTIONALITY OF THE BUTTON. THE DOWN BUTTON IS PERMANENTLY ACTIVE DUE TO EXTERNAL MECHANICAL DAMAGE. THE UP BUTTON PASSED THE FUNCTIONAL INVESTIGATION SUCCESSFULLY AND COMPLIES WITH THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE 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

    ON (B)(6) 2013, IT WAS REPORTED THAT THE UP AND DOWN BUTTONS ON THE PATIENT'S INFUSION DEVICE WERE NOT FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135105 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR