BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3061844 · Received April 16, 2013

    Report

    Report Number
    2183996-2013-00681
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 9, 2013
    Report Date
    June 13, 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
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTCOMPONENTS OF THE CHECK BUTTON IS WORN DOWN HEAVILY. THEREFORE MOISTURE ENTERED THE INSULIN PUMP AND CAUSED DAMAGES TO THE BUTTONS AND PUMP ELECTRONICS. THE CHECK BUTTON DOES NOT RESPOND TO COMMANDS DUE TO THE CONTAMINATION INSIDE THE BUTTON. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    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 CHECK BUTTON ON THE PATIENT'S INFUSION DEVICE WAS ONLY FUNCTIONING INTERMITTENTLY. 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
    162744 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1