BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU - CHEK SPIRIT COMBO

    MDR report key: 2896338 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01897
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE SOFT COMPONENTS 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 PUMP ELECTRONICS. THE BUTTONS FUNCTION WERE TESTED SUCCESSFUL AND MEET THE SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT ALL OF THE BUTTONS ON THE PT'S INFUSION DEVICE WERE INTERMITTENTLY NOT FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU - CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES