BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXI 800 ACCESS IMMASSY W/DUAL GANTRY

    MDR report key: 17117178 · Received June 13, 2023

    Report

    Report Number
    2122870-2023-00071
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590369231
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS (B)(6). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: INITIAL SERVICE WAS DISPATCHED ON 26MAY 2023. THE FIELD SERVICE ENGINEER (FSE) REMOVED WASH WHEEL AND FOUND LIQUID INSIDE SIMILAR AS WASH BUFFER. FSE CLEANED WELL AND WASH WHEEL. NO BLOCKAGES AND LEAKS WERE OBSERVED WITH ASPIRATE AND DISPENSE PROBE CONNECTIONS, WASH WHEEL WAS WELL ALIGNED. A NEW SERVICE WAS DISPATCHED ON 29MAY2023 TO REPLACE FAULTY RIBBON CABLE. DILUTION TEST PIPETTOR BIAS FAILED FOR DAP PIPETTOR 1 (-4.08% FOR A CRITERION OF +/- 4%) CONSEQUENTLY PIPETTOR 1 WAS DISABLED. 50 REPLICATES OF WASH PICK AND PLACE EXERCISER WAS PERFORMED. SYSTEM CHECK AND HS SYSTEM CHECK PASSED ON 29MAY2023. ON 30MAY2023, THE FSE REPORTED AN EXCESSIVE SLIPPAGE ON Z-AXIS. INCUBATOR PICK AND PLACE, REAGENT PACK, SAMPLE WHEEL AND WASH WHEEL ALIGNMENTS WERE VERIFIED. RED AND WHITE CONNECTIONS WERE REPLACED. ON 31MAY2023, PIPETTOR 4 FAILED MATCHING AND PIPETTOR 3 FAILED ULTRASONIC ADJUSTMENT. THE FSE REBUILT REAGENT PIPETTOR PUMPS AND REPLACED REAGENT PIPETTOR 3 TRANSDUCER. FSE REPORTED THAT WASH PICK AND PLACE EJECTOR WAS TIGHT IN REACTION VESSEL (RV) GRIPPER: HE REPLACED IT. THE FSE ALSO ADJUSTED POSITION OF HALL EFFECT SENSOR. QUALITY CONTROL, SYSTEM CHECK AND PIPETTOR MATCHING PASSED ON 31MAY2023. NO FURTHER ISSUE WAS REPORTED. IN CONCLUSION, THERE IS SUFFICIENT EVIDENCE PROVIDED TO REASONABLY SUGGEST A HARDWARE MALFUNCTION WAS THE CAUSE OF THIS EVENT. DUE TO MULTIPLE INTERVENTIONS PERFORMED, A SPECIFIC PART CANNOT BE IDENTIFIED AS THE SOLE CONTRIBUTOR OF THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE CUSTOMER REPORTED OBTAINING FALSE ELEVATED RESULTS FOR MULTIPLE ASSAYS INVOLVING THE LABORATORY'S DXI 800 ACCESS IMMUNOASSAY W/DUAL GANTRY ANALYZER (SERIAL NUMBER: (B)(6). ONE PATIENT SAMPLE WAS RUN ON HSTNI ASSAY WITH FALSE ELEVATED RESULTS AND A HIGH HSTNI RESULT WAS REPORTED OUT OF THE LABORATORY, AMENDED AND RELATED TO AN UNKNOWN SERIOUS INJURY. THE CUSTOMER REPORTED THAT THIS PATIENT HAD A CHANGE IN TREATMENT DUE TO THE ERRONEOUSLY HIGH HSTNI RESULT. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2023, THE INITIAL HSTNI DUPLICATE PATIENT SAMPLE RESULTS WERE ELEVATED (10,201 AND 10,115 NG/L) AT 04:09 PM. THE PATIENT SAMPLE WAS RETESTED ON THE SAME INSTRUMENT WITH SIMILAR HIGH RESULTS (11,835 AND 12,482 NG/L) AT 04:26 PM BUT STILL QUESTIONED. THERE WAS NO INDICATION OF CARRYOVER AS THE CUSTOMER DID NOT REPORT OBTAINING HIGH HSTNI SAMPLE RESULTS PRIOR THE QUESTIONED RESULTS AND THE ISSUE OCCURRED ON MULTIPLE ASSAYS. THEN, THE SAMPLE WAS RETESTED IN DUPLICATE ON ANOTHER INSTRUMENT (SERIAL NUMBER: (B)(6) WITH EXPECTED RESULTS OF 12.38 NG/L AND 11.68 NG/L. SYSTEM CHECK PASSED ON 22MAY2023 AND 23MAY2023. CALIBRATION DATA WAS NOT PROVIDED. FERRITIN, FOLATE, HSTNI, PCT, PSA, TSH AND VITAMIN B12 QUALITY CONTROLS (QC) WERE PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES ON THE MORNING OF THE 25MAY2023 (10:47 AM, 11:10 AM). HSTNI, PSA AND TSH QC WERE OUT OF THE RANGES (QUALITY CONTROL FAILURE - QCF FLAG) DURING THE AFTERNOON (04:59 PM, 05:11 PM). FOLATE AND FERRITIN QC WERE CANCELLED DUE TO A SYSTEM ERROR AT THIS TIME. ALL THE QC CAME BACK TO EXPECTED VALUES AT THE END OF 25MAY2023 (08:20 PM, 08:43 PM) EXCEPT QC LEVEL 3 OF VITAMIN B12. HARDWARE ERRORS REGARDING WASH PICK AND PLACE ERROR, SUBSTRATE MOTION ERROR, LUMINOMETER DARK COUNT ERROR AND AIR IN SUBSTRATE LINE WERE REPORTED ON 25MAY2023 BETWEEN 02:28 PM AND 03:42 PM RESULTING TO MULTIPLE SYSTEM ERRORS AND ONE QSB FLAG (SUBSTRATE DISPENSE ERROR). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO ASSESS INSTRUMENT PERFORMANCE ON (B)(6) 2023. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190257 DXI 800 ACCESS IMMASSY W/DUAL GANTRY ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXI 800 ACCESS IMMASSY W/DUAL GANTRY 15099590369231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other