BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3233447 · Received July 18, 2013

    Report

    Report Number
    2183996-2013-01325
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 16, 2013
    Report Date
    September 10, 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
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. E7105 ERRORS WERE FOUND IN THE HISTORY. DUE TO A USER ERROR DURING THE CARTRIDGE CHANGE, THE INSULIN PUMP CORRECTLY TRIGGERED THE E7105 ERROR MESSAGES. THE ANALYSIS OF THE HISTORY GAVE EVIDENCE THAT THE CARTRIDGE WAS INTRODUCED INTO THE CARTRIDGE COMPARTMENT WHILE THE PUMP DRIVE WAS PERFORMING A REWIND, OR THE CARTRIDGE WAS NOT REMOVED BEFORE THE REWIND STARTED. THE FUNCTIONALITY OF THE BUTTONS WAS TESTED SUCCESSFULLY AND COMPLIES WITH THE PRODUCT SPECIFICATIONS.

    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 E7 ELECTRONIC ERROR WHILE IN THE RUN MODE. SHE REPLACED THE BATTERY AND BATTERY COVER BUT WAS UNABLE TO CLEAR THE ERROR MESSAGE. FURTHER, SHE FOUND THE CHECK BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION. 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
    335102 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR