BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2992023 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-00340
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 26, 2013
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOWN BUTTON DOES NOT OPERATE. THE CONNECTIONS OF THE DOWN FLEX PRINT ARE INTERRUPTED.

    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

    ON (B)(4) 2013, IT WAS REPORTED THAT THE DOWN BUTTON ON THE PATIENT'S INFUSION DEVICE WAS NO LONGER FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97767 ACCU-CHEK SPIRIT INSULIN INFUSION DEVICE LZG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1