BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3840382 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03864
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 DID NOT CORRECTLY PROVIDE AN E1 CARTRIDGE EMPTY ERROR ON (B)(6) 2014. ON (B)(6) 2014, THE PISTON ROD STOPPED AFTER 40 IE WERE DELIVERED, AND THE INFUSION DEVICE DID NOT DISPLAY AN ERROR MESSAGE. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318400 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 004 YR