BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX ANALYZER

    MDR report key: 10223076 · Received July 2, 2020

    Report

    Report Number
    3002807968-2020-00026
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 7, 2020
    Report Date
    December 4, 2020
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930909
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE RADIOMETER INVESTIGATION PERFORMED IT WAS FOUND THAT QUALITY CONTROLS AND CALIBRATIONS WERE OK, AND THAT THE THB DEVIATIONS ARE MOST LIKELY CAUSED BY EITHER: BAD MIXING OF THE SAMPLE OR CLOTS IN THE SAMPLE. IN COMPONENT CODES, CODE 4756 HAS BEEN CHOSEN AS THERE ARE NO CODE THAT FITS THE DESCRIPTION FOR THIS EVENT. THE RADIOMETER INVESTIGATION DOES NOT POINT TO THAT A COMPONENT IN THE ANALYZER WAS THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, A CUSTOMER REPORTS THAT AN ABL90 FLEX ANALYZER GAVE DISCREPANT RESULTS FOR PATIENT MEASUREMENTS FOR THE HEMOGLOBIN PARAMETER AT (B)(6) 2020: FOR ALL PATIENTS THE SAMPLE WAS DRAWN AND TESTED AT THE SAME TIME PATIENT 1, NO. 483937. 6:00H HEMOGLOBIN VALUE: ABL90 FLEX: 38G/L; CBC: 104G/L AT 8:00 A.M. PATIENT 4, NO. 485013. 6:00H HEMOGLOBIN VALUE: ABL90 FLEX:166G/L; CBC: 94G/L AT 8:00 A.M. PATIENT 6, NO. 485586. 6:00H HEMOGLOBIN VALUE: ABL90 FLEX:190G/L; CBC: 112G/L AT 8:00 A.M. PATIENT 7, NO. 132237. 6:00H HEMOGLOBIN VALUE: ABL90 FLEX:186G/L; CBC: 66G/L AT 8:00 A.M. ON (B)(6) 2020 PATIENT 7 WAS TESTED AGAIN. THE SAMPLE WAS DRAWN AND TESTED AT THE SAME TIME: PATIENT 7, NO.132237. 6:00H HEMOGLOBIN VALUE: ABL90 FLEX:1.3G/L; CBC RESULT WAS 69G/L AT 8:00 A.M. BASED ON THE MEASUREMENTS ABOVE, THE DISCREPANCIES HAVE BEEN CALCULATED TO: (B)(6). THE CUSTOMER REPORTS THAT, SEVERAL PATIENT RESULTS WERE SERIOUSLY DIFFERENT FROM PATIENTS' CONDITION, WHICH EFFECTED THE DOCTOR'S JUDGEMENT, AND PLAYED A MISLEADING ROLE. THE CUSTOMER HAS STOPPED USING THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687592 ABL90 FLEX ANALYZER ABL90 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-090 05700693930909

    Patients

    Seq Age Sex Outcome Treatment
    1