BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 2992001 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-00331
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 10, 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
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. E8 ERRORS WERE FOUND IN THE HISTORY. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND DESTROYED THE FUNCTIONALITY OF THE BUTTONS AND THE ELECTRONICS. THE UP BUTTON IS PERMANENTLY ACTIVE DUE TO EXTERNAL MECHANIC DAMAGE. THE PUMP CORRECTLY TRIGGERED AN E8 ERROR AS A RESULT OF THE POWER INTERRUPTION WHILE THE PUMP WAS IN RUN MODE.

    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 THE BUTTONS ON THE INFUSION DEVICE ARE NON-FUNCTIONAL. HE EXPERIENCED HYPERGLYCEMIA OF 240 MG/DL 1 MONTH AGO AND WAS UNABLE TO PROGRAM A CORRECTION BOLUS. HE REMOVED AND REINSERTED THE BATTERY, AND AN E8 POWER INTERRUPT ERROR APPEARED. HE SWITCHED TO HIS BACKUP INFUSION DEVICE, AND THE ALLEGED INFUSION DEVICE WAS REQUESTED FOR EVALUATION. HE 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
    97699 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1