BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3220996 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01261
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 4, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    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

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT E8 WAS FOUND IN THE HISTORY LIST. THE SOFTCOMPONENTS 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 PUMP ELECTRONICS. THE UP BUTTON IS SEPARATED FROM THE FLEX PRINT. THEREFORE, IT IS NOT POSSIBLE TO OPERATE THE PUMP. THE PUMP CORRECTLY TRIGGERED AN E8 ERROR AS A RESULT OF THE POWER INTERRUPT WHILE THE PUMP WAS IN RUN MODE. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED AFTER CHANGING THE BATTERIES ON THE INFUSION DEVICE IT DOES NOT WORK. PATIENT STATED THERE IS AN E8 (POWER INTERRUPT) ON THE DISPLAY OF THE DEVICE. PATIENT REPORTED THAT ALL OF THE BUTTONS ON THE INFUSION DEVICE DOESN'T RESPOND TO ANY COMMAND. PATIENT STATED THE INFUSION DEVICE SEEMS AS THOUGH IT IS LOCKED. PATIENT REPORTED HE CHANGED TO NEW BATTERIES BUT THE PROBLEMS STILL PERSISTS. PATIENT STATED HE DID NOT HAVE A CHANCE TO ENTER ANYTHING. PATIENT REPORTED THAT THE BUTTONS ON THE SIDE OF THE INFUSION DEVICE ARE COMPLETELY CONSUMED. 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
    320435 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1