BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 6864115 · Received September 14, 2017

    Report

    Report Number
    3002807968-2017-00030
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 8, 2017
    Report Date
    November 21, 2017
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938004
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN RELATION TO THIS CASE A RECALL (RADIOMETER REF (B)(4)) WAS ISSUED 2017-10-02 AND REPORTED TO FDA 2017-10-17 BY RADIOMETER AMERICA, INC.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, AT CUSTOMER'S PLACE, SAMPLE MEASUREMENT IS DONE USING FLEXQ AND THE REGISTRATION RECEIPT BARCODE IS CREATED AUTOMATICALLY. IF THE CUSTOMER WANTS TO SEE A PATIENT'S DATA DIRECTLY ON THE ANALYZER IT IS MADE EASIER BY USING THE REGISTRATION RECEIPT BARCODE. IN THIS CASE, WHEN THE REGISTRATION RECEIPT BARCODE (FOR SAMPLE NUMBER: (B)(4)) WAS READ BY THE ANALYZER, THE ANALYZER PRESENTED THE RESULT FROM A DIFFERENT PATIENT (FOR SAMPLE NUMBER: (B)(4)). THE ISSUE WAS DISCOVERED SINCE A MISMATCH EXISTED BETWEEN THE PATIENT IDENTIFICATION INFORMATION ON THE REGISTRATION RECEIPT AND THE PATIENT IDENTIFICATION INFORMATION ON THE PRESENTED RESULT. RADIOMETER COMMENTS: WHATEVER INFORMATION CUSTOMERS USE TO IDENTIFY PATIENTS, THIS INFORMATION WILL BE SHOWN ON BOTH THE REGISTRATION RECEIPT AND THE RESULT RETRIEVED - HENCE THE RECEIVED COMPLAINT COVERS A CASE OF INCORRECT PATIENT RESULT RETRIEVAL. NOTE, THAT THIS CASE IS NOT CONCERNING BARCODE ON SAMPLER. IT CONCERNS A BARCODE ON A REGISTRATION RECEIPT GENERATED BY THE ABL800 FLEX-Q WHEN A SAMPLE IS QUEUED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644557 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 383-800 05700693938004

    Patients

    Seq Age Sex Outcome Treatment
    1