BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 9859941 · Received March 20, 2020

    Report

    Report Number
    3002807968-2020-00012
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    February 20, 2020
    Report Date
    May 14, 2020
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Removal / Correction Number
    3002807968-05/14/20-006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOMETER HAS DECIDED TO INITIATE RECALL WITH RADIOMETER REF. FAN 915-412 IN ORDER TO CORRECT THE ISSUE AT ALL AFFECTED CUSTTOMERS. THE PERMANENT COUNTERMEASURE WILLL BE A NEW SOFTWARE VERSION WHERE THIS ISSUE IS CORRECTED.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, THE CUSTOMER EXPERIENCED THAT THE ABL800 ANALYZER LINKED A PREVIOUS NUMBER WITH A NEW SAMPLE WITH ANOTHER NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325035 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1