BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 9792154 · Received March 5, 2020

    Report

    Report Number
    3002807968-2020-00004
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    January 27, 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 CUSTOMERS. THE PERMANENT COUNTERMEASURE WILL BE A NEW SOFTWARE VERSION WHERE THIS ISSUE IS CORRECTED.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, A PATIENT RESULT MEASURED ON THE ABL800 FLEX ANALYZER GOT INCORRECT PATIENTID AND OPERATOR. NO LOGS INDICATES ANYTHING HAS BEEN CHANGED AFTER THE MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256455 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1