BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3851566 · Received June 5, 2014

    Report

    Report Number
    1823260-2014-04034
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 23, 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

    PATIENT'S MOTHER REPORTED THE PUMP 'IS FALLEN' AND THE E7 (ELECTRONIC ERROR) MESSAGE APPEARED. MOTHER STATED SHE DISCONNECTED THE INFUSION SET FROM THE INFUSION SITE AND REMOVED THE BATTERIES; INSERTED NEW BATTERIES BUT ERROR APPEARS AGAIN WHEN SHE TURNS ON THE PUMP. PRELIMINARY EVALUATION ON (B)(4) 2014 FOUND THE SELF-TEST FAILED WHEN THE PUMP WAS POWERED UP USING A SERVICE BATTERY. ALSO NEITHER THE AUDIO ALERT SIGNAL NOR THE VIBRA ALERT SIGNAL WORKED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329110 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1