BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3012785 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00453
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 12, 2013
    Report Date
    April 23, 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

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT NO DEFECTIVE DISPLAY SEGMENTS WERE FOUND HOWEVER THE DISPLAY WINDOW IS SCRATCHED DUE TO A MECHANICAL IMPACT. THE SCRATCHED DISPLAY CANNOT LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS. THE INSULIN PUMP SHOULDN'T BE EXPOSED TO HIGH MECHANICAL FORCES. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A HANDLING ISSUE.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED A BLACK LINE APPEARED ON THE INFUSION DEVICE DISPLAY A FEW WEEKS AGO, AND THIS LINE INTERFERES WITH HER ABILITY 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
    115947 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR