BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3143430 · Received June 3, 2013

    Report

    Report Number
    2183996-2013-01003
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 27, 2013
    Report Date
    July 11, 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
    GM
    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 CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT THE PUMP HOUSING IS BROKEN DUE TO A HARD MECHANICAL IMPACT. DUE TO SEVERAL DAMAGES ON THE ELECTRONIC COMPONENTS THE INSULIN PUMP TRIGGERED ERROR MESSAGES. E8 WERE FOUND IN THE PUMP HISTORY. THE INSULIN PUMP SHOULDN'T BE EXPOSED TO HIGH MECHANICAL FORCES. DUE TO THIS PROBLEM THE BUTTONS OF THE PUMP CAN NOT BE OPERATED. THE PATIENT STATED THAT THE PUMP HAD INTENTIONAL WATER CONTACT. THE PUMP IS NOT WATERPROOF FOR SWIMMING OR OTHER CONTACTS WITH WATER. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A HANDLING ISSUE.

    Description of Event or Problem · 1

    PATIENT'S FATHER REPORTED THE INFUSION DEVICE WAS DROPPED IN WATER. FATHER STATED THE PATIENT WAS SWITCHED TO THE BACKUP INFUSION DEVICE. FATHER REPORTED 2 DAYS LATER HE ATTEMPTED TO START THE INFUSION DEVICE WHICH HAD BEEN DROPPED IN WATER AND THE DEVICE WAS STARTING UP WITH AN E8 (POWER INTERRUPT). FATHER STATED HE WANTED TO CONFIRM THE ERROR BUT WAS WITHOUT SUCCESS. FATHER REPORTED THE CHECK BUTTON ON THE INFUSION DEVICE IS WITHOUT FUNCTION. 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. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245268 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1