BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX PLUS

    MDR report key: 16609409 · Received March 24, 2023

    Report

    Report Number
    3002807968-2023-00010
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 11, 2023
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930923
    PMA / PMN Number
    K160153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE RADIOMETER INVESTIGATIONS, THE PRODUCT DID NOT FAIL TO MEET ITS SPECIFICATIONS AND THE ROOT CAUSE WAS CONCLUDED TO BE PRE-ANALYTICAL HANDLING. HENCE, THE PRODUCT WORKED AS INTENDED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, THE CUSTOMER EXPERIENCED DISCREPANT RESULTS ON CTHB (TOTAL HEMOGLOBIN) WHEN USING AN ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER:(B)(4). COMPARISON WAS MADE WITH THE COUNTING METHOD (HAEMATOLOGY). FILE NUMBER - ABL RESULTS COUNT RESULT UNITS (B)(6) - 13,4 13,2 G/DL , (B)(6) - 12,2 1 0,4 G/DL , (B)(6) - 8,2 7,4 G/DL , (B)(6)- 12,9 12,4 G/DL, (B)(6) - 9,9 9,7 G/DL, (B)(6)* 7,1 10,5 G/DL, (B)(6)* 4,1 12,2 G/DL , (B)(6) - 7,7 8,2 G/DL , (B)(6) - 16,7 15,5 G/DL , (B)(6) - 10,3 10,4 G/DL , (B)(6) - 10,8 10,6 G/DL , (B)(6) - 12,7 12,4 G/DL, (B)(6) - 10,3 10,1 G/DL , THE CUSTOMER REPORTED THE ABL90 FLEX PLUS MEASUREMENTS 7,1 AND 4,1 G/DL (MARKED WITH ASTERISKS ON THE FILE NUMBERS) AS FALSE LOW BASED ON THE COMPARISON MEASUREMENTS AND THE PATIENT'S GENERAL HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360739 ABL90 FLEX PLUS ABL90 FLEX PLUS CHL RADIOMETER MEDICAL APS 393-092 05700693930923

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male