BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3896280 · Received June 26, 2014

    Report

    Report Number
    1823260-2014-04695
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED SOMETIMES THERE IS NON-FUNCTION OF THE OK BUTTON ON THE PUMP. CALLER STATED SHE CHANGED THE BATTERY AND NOW THE PUMP STARTS WITH AN E8 (POWER INTERRUPT) ERROR MESSAGE. CALLER REPORTED SHE IS UNABLE TO CONFIRM THE E8 MESSAGE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375147 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR