BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4100895 · Received September 19, 2014

    Report

    Report Number
    1823260-2014-07154
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 25, 2014
    Report Date
    November 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
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE INFUSION DEVICE SHUT-DOWN WITHOUT PROVIDING AN ERROR MESSAGE ON 3 SEPARATE OCCASIONS. THE INFUSION DEVICE RESTARTED BY ITSELF AND THEN PROVIDED AN E8 POWER INTERRUPT ERROR. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584902 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1