BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3212353 · Received July 9, 2013

    Report

    Report Number
    2183996-2013-01228
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    July 5, 2013
    Report Date
    September 6, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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 A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CAN BE VERIFIED. RESULT THE CHECK BUTTON DOES NOT RESPOND. THERE ARE PARTICLES OF PLASTIC INSIDE THE HOUSING OF THE CHECK BUTTON. THE PARTICLES TEMPORARY ISOLATE THE AREA OF CONTACT INSIDE THE BUTTON HOUSING. DUE TO THIS PROBLEM THE CHECK BUTTON DOES NOT RESPOND AND IS WITHOUT FUNCTION.

    Description of Event or Problem · 1

    PATIENT REPORTED THE CHECK BUTTON ON THE INFUSION DEVICE DOES NOT OPERATE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314496 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1