BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3100475 · Received May 8, 2013

    Report

    Report Number
    2183996-2013-00809
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    February 17, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO MISUSE OF THE PRODUCT. RESULT THE DISPLAY IS BROKEN DUE TO A MECHANICAL IMPACT. THE BROKEN DISPLAY CAN LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISUSE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    PATIENT REPORTED THERE ARE TWO BLACK LINES IN THE MIDDLE AND THE TOP OF THE INFUSION DEVICE. PATIENT STATED THE 2 BLACK LINES DID NOT AFFECT THE VIEWING OF THE HOURLY BASAL RATE. ON (B)(6) 2013 UPON EVALUATION IT WAS DETERMINED THAT THE BROKEN DISPLAY COULD LEAD TO MISINTERPRETATION OF THE INSULIN DELIVERY AMOUNTS. 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. INFUSION DEVICE HAS BEEN RECEIVED AND EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200760 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR