BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3220740 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01249
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 26, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1646-2009
    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 LIST. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND DESTROYED THE PUMP ELECTRONICS. THE BUTTONS PASSED THE FUNCTIONAL INVESTIGATION SUCCESSFULLY AND COMPLY WITH THE PRODUCT SPECIFICATIONS. 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

    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 THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE DISPLAYED AN E8 POWER INTERRUPT ERROR THAT COULD NOT BE CLEARED BY PRESSING THE CHECK BUTTON. HE REPORTED THE INFUSION DEVICE "KEPT RINGING" AND THE BOLUS SCREEN WAS DISPLAYED. THE BUTTONS WERE UNRESPONSIVE, AND HE REMOVED AND REINSERTED THE BATTERY. THE INFUSION DEVICE THEN DISPLAYED THE E8 ERROR MESSAGE. THE INFUSION DEVICE WAS NOT DROPPED. HE SWITCHED TO HIS BACKUP INFUSION DEVICE, AND THE ALLEGED INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND 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
    319612 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1