BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2943298 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00014
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 9, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE DISPLAY PASSED THE OPTICAL AND FUNCTIONAL INVESTIGATION SUCCESSFUL AND MEETS THE SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED SOME CHARACTERS ON THE INFUSION DEVICE DISPLAY ARE MISSING. THE CORRECT TYPE OF BATTERY IS USED. HE CHANGED THE BATTERY SEVERAL TIMES BUT WAS UNABLE TO RESOLVE THE ISSUE. THE INFUSION DEVICE WAS IN STOP AT THE TIME OF THE CALL, AND THE TOP HALF OF THE SYMBOL AND THE TIME AND DATE WERE NOT VISIBLE. THE INFUSION DEVICE WAS NOT DROPPED, AND THERE IS NO DAMAGE TO THE SCREEN. HE IS UNABLE TO SEE ALL OF THE NUMBERS FOR THE INSULIN DELIVERY AMOUNTS. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29123 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN