BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3141297 · Received June 3, 2013

    Report

    Report Number
    2183996-2013-00997
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 26, 2013
    Report Date
    June 25, 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
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTCOMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE MOISTURE ENTERED THE INSULIN PUMP AND DESTROY THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON IS PERMANENT ACTIVE DUE TO AN EXTERNAL MECHANIC DAMAGE.

    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 PATIENT'S INFUSION DEVICE DISPLAYED E8 (POWER INTERRUPT), BUT SHE WAS UNABLE TO CLEAR THE ERROR BECAUSE THE CHECK BUTTON WAS 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. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245022 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 023 YR