BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3953437 · Received July 23, 2014

    Report

    Report Number
    1823260-2014-05462
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    PATIENT REPORTED THE PUMP WON'T ALLOW HER TO PRESS ANY BUTTONS. PATIENT REPORTED SHE REMOVED THE BATTERY BEFORE THE CALL AND NOW SHE CAN'T GET THE E8 (POWER INTERRUPT) MESSAGE OFF OF THE SCREEN. PATIENT REPORTED THE BUTTONS ARE NOT RESPONDING. PATIENT STATED THE ISSUE IS CONSTANT. PATIENT REPORTED SHE INSERTED A NEW BATTERY; PUMP DOESN'T WORK. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP AND CARTRIDGE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430188 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1