BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 2992016 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-00333
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 5, 2013
    Report Date
    May 9, 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
    FI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE DISPLAY LEGIBILITY IS RESTRICTED DUE TO AN INTERRUPTION OF THE HEAT-SEAL CONNECTION, AND THIS DOES NOT INTERFERE WITH VIEWING THE INSULIN DELIVERY AMOUNTS.

    Description of Event or Problem · 1

    PATIENT REPORTED THERE IS A VERTICAL LINE IN THE DISPLAY WHERE THE TIME AND INSULIN HISTORY ARE DISPLAYED. SHE REPORTED IT "EATS" HALF OF THE DISPLAY AND MAKES IT DIFFICULT TO VIEW THE INSULIN DELIVERY AMOUNTS. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97682 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR