BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS INTACT PTH

    MDR report key: 20641291 · Received November 8, 2024

    Report

    Report Number
    9680746-2024-00003
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    June 28, 2024
    Report Date
    November 8, 2024
    Manufacturer
    BECKMAN COULTER IRELAND, INC
    Product Code
    CEW
    UDI-DI
    15099590201937
    PMA / PMN Number
    K232791
    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 CASE: (B)(4). FOURTEEN (14) PATIENTS ARE INVOLVED IN THIS EVENT. PATIENTS HAD NO CHANGE TO PATIENT MANAGEMENT (TREATMENT OR SERIOUS INJURY). A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NO HARDWARE ISSUE WAS REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER ASSAY RESULT WAS QUESTIONED. AN ARCHIVE FILE ¿DXI5 1¿ WAS PROVIDED; IT CONTAINS THE QUESTIONED PATIENT¿S RESULTS. NO RESULT WAS FLAGGED. THERE IS NO ERROR MESSAGE ABOUT ANY HARDWARE ISSUE AT TIME OF THE EVENT. THE LOCAL APPLICATION ENGINEER CHECKED 25 RANDOM SAMPLES WHICH WERE NOT QUESTIONED. THE CUSTOMER IS EXPECTING A 10.6 % BIAS. MOST OF SAMPLES WERE REPEATED THREE TIMES AND SHOW REPEATABLE VALUES. THE COA (CERTIFICATE OF ANALYSIS) FOR PTH REAGENT PART NUMBER: A16972, LOT NUMBER: 472012 AVAILABLE ON EDMS WAS REVIEWED INDICATING THE PRODUCT MANUFACTURED ON 01JAN2024 AND EXPIRING ON 31DEC2024 MET RELEASE SPECIFICATIONS. ON (B)(6) 2024: FURTHER INVESTIGATION WAS PERFORMED ON-SITE PER BECKMAN COULTER BETWEEN ON (B)(6) 2024. ON (B)(6) 2024, A DATA ANALYSIS OF CUSTOMER¿S RAW DATA HIGHLIGHTED THAT THE 14 PATIENT SAMPLES THAT GENERATED DISCREPANT RESULTS WERE DELAYED ON-BOARD, PRIOR TO BEING PROCESSED, IN THE SAMPLE WHEEL OF DXI-5, FOR A PERIOD GREATER THAN 10 MINUTES. PER ¿DXI 9000 DISCREPANT PTH RESULTS INVESTIGATION REPORT¿, INITIALLY RELEASED ON 14OCT2024 AND ¿PLRA FOR DXI 9000 DISCREPANT PTH PATIENT SAMPLES¿: A MEDIAN DOSE CHANGE OF -25% WAS OBSERVED ACROSS THE PTH RANGE, AFTER AT LEAST 10 MINUTES DELAY. SAMPLES COLLECTED IN PLASMA TUBES (K2-EDTA, K3-EDTA, LITHIUM HEPARIN ¿ AVERAGE DOSE DIFFERENCE OF -28.8%, -29.1% AND -28.6% ON DXI 9000 INSTRUMENT) WERE MORE IMPACTED THAN SAMPLES COLLECTED IN SERUM TUBE (AVERAGE DOSE DIFFERENCE OF -8.2% ON DXI 9000 INSTRUMENT). ON SEPTEMBER 2024, AN INTERNAL STUDY WAS PERFORMED, DIFFERENT PATIENT SAMPLE TYPES (SERUM AND PLASMA) WERE TESTED ON BOTH DXI 9000 AND DXI 800 PLATFORMS AND CONFIRMED A DOSE DECREASE WHEN PLASMA SAMPLES ARE TESTED AFTER AN INCREASED STORAGE TIME ON THE INSTRUMENT SAMPLE WHEEL. BOTH CUSTOMER DATA AND DATA GENERATED INTERNALLY BY BECKMAN COULTER CONFIRMED THAT THE ISSUE IS SPECIFIC TO PATIENT SAMPLES AND NOT SEEN WITH CALIBRATORS OR QUALITY CONTROLS (QC). ON OCTOBER 2024, A BIOSTATISTICAL ANALYSIS WAS PERFORMED AND LED TO THE FOLLOWING CONCLUSION: A NON-CONFORMANCE TO THE ASSAY IMPRECISION REQUIREMENT WAS CONFIRMED FOR PLASMA SAMPLES DELAYED WITH 60 MINUTES ON DXI 9000 INSTRUMENT WITH PTH ROUTINE TEST. A CAPAREQUEST WAS INITIATED ON 11OCT2024. ON 14OCT2024, THE INVESTIGATION REPORT WAS RELEASED. CAPA: 001244 WAS OPENED ON 5NOV2024. A FIELD ACTION LETTER DOCUMENT NUMBER FA-24060 WAS SENT TO CUSTOMERS. IN CONCLUSION, THERE IS EVIDENCE OF A NON-CONFORMANCE, CONFIRMED DURING AN INTERNAL STUDY, AS THE ASSAY IMPRECISION REQUIREMENT IS NOT MET FOR PLASMA SAMPLES. THIS IS CAUSED BY A DELAY IN PROCESSING SAMPLES ON THE DXI 9000 INSTRUMENT WITH THE ACCESS PTH ROUTINE. A 35% DOSE DROP WAS OBSERVED WHEN A PLASMA SAMPLE IS STORED ON THE SAMPLE WHEEL INSIDE DXI 9000 FOR >1HOUR AND TESTED WITH PTH ROUTINE MODE. THIS EVENT IS RELATED TO CAPA: 001244. INVESTIGATION TO ROOT CAUSE WILL BE PERFORMED AS PART OF THE CAPA. NOTE: BECKMAN BECAME AWARE THAT THIS EVENT REPRESENTS A MALFUNCTION WHEN THE INVESTIGATION REPORT, CONFIRMING THAT THE ASSAY IMPRECISION WAS NOT MET, WAS APPROVED BY ALL SUBJECT MATTER EXPERTS AND RELEASED ON 14OCT2024.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE CUSTOMER REPORTED DISCREPANT PTH (ACCESS INTACT PTH, PART NUMBER: A16972 AND LOT NUMBER: 472012) RESULTS WERE GENERATED BETWEEN THE CUSTOMER'S DXI 9000 SERIAL NUMBERS S/N: (B)(6). THE CUSTOMER REPORTED FOURTEEN (14) PATIENT SAMPLES WITH A SIGNIFICATIVE DIFFERENCE UPON REPEAT BETWEEN TWO DXI 9000 INSTRUMENTS S/N: (B)(6) (REFER TO RELEVANT TESTS SECTION BELOW). HOWEVER, ALL RESULTS WERE ELEVATED AND ABOVE THE PTH EXPECTED VALUES: 12-88 NG/L. PER CUSTOMER VERBAL REPORT, THE ISSUE WAS FIRST NOTED ON (B)(6) 2024. THE DATA PROVIDED SHOWS PTH PATIENT RESULTS OBTAINED ON THE CUSTOMER¿S DXI 9000 ANALYZER SERIAL NUMBER: (B)(6) (DXI-5) ARE BETWEEN -17% TO -57% LOWER THAN THE RESULTS OBTAINED ON THE OTHER DXI 9000 ANALYZER (DXI-1 - SERIAL NUMBER: (B)(6). THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS INCIDENT. NO HARDWARE ISSUES, NO FLAGS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER ASSAY RESULT WAS QUESTIONED. DXI 9000 S/N: (B)(6): CALIBRATION PASSED ON (B)(6) 2024 WITH REAGENT LOT: 472012 AND CALIBRATOR LOT: 489727. FOR MONTH OF JUNE 2024: QUALITY CONTROL (QC) LEVEL 3 WAS ERRATICALLY OUTSIDE HIGH OF THE 2SD RANGE. QC LEVEL 2 PASSED WITHIN ESTABLISHED LABORATORY¿S RANGE. QC LEVEL 1 WAS ERRATICALLY OUTSIDE LOW OF THE 2SD RANGE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLES WERE ROUTED FROM THE DXA TRACK AFTER THE CENTRIFUGATION (4000 G FOR 4 MINUTES) INTO THE DXI 9000. THEY WERE NOT RECENTRIFUGED BEFORE BEING REPEATED. IT IS STATED SAMPLES WERE TESTED WITHIN TIME FRAME OF THE PTH INSTRUCTIONS FOR USES. THE LOCAL APPLICATION ENGINEER CHECKED 25 RANDOM SAMPLES WHICH WERE NOT QUESTIONED. THE CUSTOMER IS EXPECTING A 10.6 % BIAS BETWEEN THE RESULTS OBTAINED ON THE TWO DIFFERENT DXI 9000 ANALYZERS. MOST OF SAMPLES WERE REPEATED THREE TIMES AND SHOW REPEATABLE VALUES. FURTHER INVESTIGATION WAS PERFORMED ON-SITE PER BECKMAN COULTER BETWEEN ON (B)(6) 2024. NOTE: BECKMAN BECAME AWARE THAT THIS EVENT REPRESENTS A MALFUNCTION WHEN THE INVESTIGATION REPORT, CONFIRMING THAT THE ASSAY IMPRECISION WAS NOT MET, WAS APPROVED BY ALL SUBJECT MATTER EXPERTS AND RELEASED ON 14OCT2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944732 ACCESS INTACT PTH RADIOIMMUNOASSAY, PARATHYROID HORMONE CEW BECKMAN COULTER IRELAND, INC 472012 15099590201937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown