BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3834576 · Received May 28, 2014

    Report

    Report Number
    1823260-2014-03738
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    March 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    CALLER REPORTED THE DOWN BUTTON ON THE PUMP IS NO LONGER RESPONDING CONSISTENTLY TO PRESSES. CALLER STATED THE BUTTON IS NOT FLAT AND THE ISSUE IS INTERMITTENT; BUTTON WORKS IF PRESSED HARD. CALLER REPORTED THE ISSUE HAS BEEN OCCURRING FOR ABOUT 2 MONTHS. CALLER STATED THE BUTTON DOES NOT MAKE AN AUDIBLE SOUND BUT IT DOES VIBRATE WHEN PRESSED HARD. PATIENT REPORTED THE RUBBER HOUSING OVER THE BUTTONS IS PEELING OFF; CANNOT SEE THE METAL PLATE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313842 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR