BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3040225 · Received April 8, 2013

    Report

    Report Number
    2183996-2013-00602
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 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
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. THE SOFT COMPONENTS OF THE UP AND DOWN BUTTONS ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND CAUSED DAMAGES TO THE PUMP ELECTRONICS. THE SHUT-DOWN OF THE INSULIN PUMP IS A CONSEQUENCE ERROR OF THE DAMAGED PUMP ELECTRONICS DUE TO LIQUID INGRESS. THE DAMAGES DID NOT INFLUENCE THE FUNCTIONS OF THE PUMP BUTTONS.

    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

    PATIENT REPORTED THE INFUSION DEVICE MADE AN ABNORMAL NOISE, AND HE CHECKED THE DISPLAY AND NOTICED IT WENT IN AND OUT OF THE QUICK BOLUS MODE BY ITSELF. HE REPORTED THE BUTTONS ON THE INFUSION DEVICE WOULD NOT FUNCTION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143426 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR