BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 12567014 · Received October 4, 2021

    Report

    Report Number
    3002807968-2021-00041
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 9, 2021
    Report Date
    April 21, 2022
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938011
    PMA / PMN Number
    K043218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOMETER INVESTIGATION IS FINALIZED AND THE ROOT CAUSE IS CONCLUDED TO BE 'SUPPLIED MATERIALS OUTSIDE SPECIFICATION.'

    Additional Manufacturer Narrative · 0

    THE RADIOMETER INVESTIGATION HAS SHOWN THAT THE PRODUCT FAILED DUE TO LEAKAGE INTO MEASUREMENT CHAMBER AROUND REFERENCE MEMBRANE. THE MEASUREMENT CHAMBER WAS CLEANED AND THE REFERENCE MEMBRANE REPLACED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION: THE MEMBRANE AND THE REFERENCE UNIT WERE REPLACED. THE PRELIMINARY RADIOMETER INVESTIGATION OF THE DESCRIBED EVENT COULD NOT CONFIRM THE FAILURE AND THE ROOT CAUSE OF THE LEAKAGE ISSUE IS STILL UNKNOWN. RADIOMETER INVESTIGATION WILL CONTINUE.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT THE REFERENCE ELECTRODE MEMBRANE LOT 2944 WAS LEAKING BLOOD IN THE MEASURING CHAMBER AND THE CUSTOMER REPORTED THE NA RESULT WAS TOO HIGH. THE DISCREPANT MEASUREMENT FOR NA WAS 156MMOL/L. (12:27AM (B)(6) 2021) AND THE COMPARISON MEASUREMENT FOR NA 135MMOL/L (12:26AM (B)(6) 2021). CALIBRATIONS DID NOT FAIL UNTIL 5:30AM (B)(6) 2021 OF THAT MORNING. FAILED PARAMETERS CURRENTLY WERE PH, NA, CA AND K. NEXT CALIBRATION WAS GOOD. THE ON-BOARD SCHEDULE QC WAS RUN AT 6:08AM, QC LEVEL 3 AND FAILED PH, NA AND CA. THE QC LEVEL 3 WAS RE-RUN AND PASSED ALL PARAMETERS. THE NEXT ON-BOARD SCHEDULED QC WAS RUN AT 8:00AM, QC LEVEL 2 FAILED PH, K AND NA. THESE PARAMETERS WERE NOW LOCKED UNTIL A PATHOLOGY STAFF COULD GO TO THE INSTRUMENT TO PERFORM MAINTENANCE AND FIX THE PROBLEM. CUSTOMER WENT TO INSTRUMENT (ABL800 FLEX ANALYZER) AND FOUND BLOOD LEAKING FROM THE REFERENCE ELECTRODE MEASURING CHAMBER. CUSTOMER CLEANED THE BLOOD FROM THE INSTRUMENT AND REMEMBRANED THE REFERENCE ELECTRODE AT 10:30AM AND RAN QC LEVEL 2 AND LEVEL 3 AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469847 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800 05700693938011

    Patients

    Seq Age Sex Outcome Treatment
    1 Male