BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3914006 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04916
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). (B)(6) LAW DOESN'T ALLOW PRODUCT RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED THE BUTTON ON THE PUMP IS NON-FUNCTIONAL. CALLER STATED THE PUMP DISPLAYED AN E8 (POWER INTERRUPT) ERROR MESSAGE AND HE REMOVED AND REINSERTED THE BATTERY. CALLER REPORTED THE MENU BUTTON WAS BLOCKED; LATER ALL OTHER BUTTONS BLOCKED. NO ADVERSE EVENT REPORTED. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391716 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 016 YR