BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3061807 · Received April 16, 2013

    Report

    Report Number
    2183996-2013-00680
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 13, 2013
    Report Date
    June 12, 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 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 CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT THE DISPLAY WINDOW IS SCRATCHED, AND THIS WAS CAUSED BY MECHANICAL IMPACT DURING USE. THE FUNCTIONALITY OF THE PUMP WAS NOT AFFECTED BY THE DAMAGES AND NO ALARM/ERROR MESSAGES WERE TRIGGERED. THE SCRATCHED DISPLAY CANNOT LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INFUSION DEVICE DISPLAY IS BLURRY, AND THIS INTERFERES WITH PATIENT'S ABILITY TO VIEW THE BASAL AND BOLUS AMOUNTS. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT 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
    163526 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1