BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY ANALYZER

    MDR report key: 11736552 · Received April 28, 2021

    Report

    Report Number
    2122870-2021-00056
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265380
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGM REAGENT WAS NOT RETURNED FOR EVALUATION. NO OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON 17MAR2021 BUT THE %CV FOR THE CALIBRATOR C0 WAS 29.56%. QC WERE PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES FROM 3MAR2021 UNTIL 6APR2021 EVEN IF THERE IS VARIATION ON THE QC LEVEL 1. THE LOCAL SUPPORT WAS DISPATCHED AND PERFORMED A CARRYOVER TEST ON THE 16APR2021 AND IT WAS PASSING. A DIL TEST WAS ALSO PERFORMED, THE FIRST RESULT WAS 40.64 %CV IT WAS REPEATED WITH A 1.68 %CV. BOTH THE LUMIAP AND THE DIL-TEST WERE PASSING WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AT CUSTOMER¿S SITE ON (B)(6) 2021. THE FSE FOUND THAT THE SPRING IN THE PRECISION PUMP DOES NOT SUFFICIENTLY PRESSURIZE THE PISTON. THE PRECISION PUMP SPRINGS WERE REPLACED, THE PRECISION PUMP WAS CLEANED, AND ALIGNMENTS WERE PERFORMED. HE PERFORMED THE DIL-TEST, RAN QC AND RAN A REPEATABILITY WHICH ALL PASSED. PER THE CURRENT SARS-COV-2 IGM TECHNICAL ASSAY GUIDE:¿ THIS IS A LOW VOLUME ASSAY; THE SAMPLE PICK UP IS 10 ¿L. LOW SAMPLE VOLUME ASSAYS ARE GENERALLY SUSCEPTIBLE TO PIPETTOR PRECISION AND PRECISION PUMP ISSUES.¿ IN CONCLUSION, THE LIKELY CAUSE OF THIS ISSUE IS A HARDWARE ISSUE OF THE PRECISION PUMP. THE FIELD SERVICE ENGINEER WAS DISPATCHED AT CUSTOMER¿S SITE AND REPLACED THE SPRINGS FROM THE PRECISION PUMP, CLEANED IT AND PERFORMED APPROPRIATE ALIGNMENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE CUSTOMER REPORTED SPORADICALLY ERRONEOUSLY REACTIVE ACCESS SARS-COV-2 IGM RESULTS FOR FIVE PATIENTS ON THE ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). ALL FIRST PATIENT RESULTS FOR THE SARS COV2 IGM ASSAY ARE REACTIVE AND BECAME NON-REACTIVE UPON REPEAT. THE SARS COV2 IGG PATIENT RESULT IS REACTIVE ONLY FOR THE PATIENT 3 (SAMPLE ID (B)(6)). THE CLINICAL PATIENT PROFILES WERE NOT PROVIDED. NO DATE OF SYMPTOMS, NO PCR TEST RESULT. (B)(6). THERE WERE A TOTAL OF FIVE (5) DIFFERENT DATES SUPPLIED TO BECKMAN COULTER IN CONJUNCTION WITH THIS EVENT. FIVE (5) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF ERRONEOUSLY REACTIVE RESULTS AT DIFFERENT DATES. THIS REPORT ADDRESS THE ERRONEOUSLY REACTIVE RESULT FOR PATIENT FOUR. MEDWATCH NUMBER ¿2122870-2021-00053¿ WILL ADDRESS PATIENT ONE ((B)(6) 2021). MEDWATCH NUMBER ¿2122870-2021-00054¿ WILL ADDRESS PATIENT TWO ((B)(6) 2021). MEDWATCH NUMBER ¿2122870-2021-00055¿ WILL ADDRESS PATIENT THREE ((B)(6) 2021). MEDWATCH NUMBER ¿2122870-2021-00057¿ WILL ADDRESS PATIENT FIVE ((B)(6) 2021). NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO SYSTEM CHECK DATA WERE PROVIDED. CALIBRATION PASSED ON 19FEB2021 WITH REAGENT LOT 971128 AND CALIBRATOR LOT 922754. CALIBRATION PASSED ON 17MAR2021 WITH REAGENT LOT 172015 AND CALIBRATOR LOT 922828 BUT THE %CV FOR THE CALIBRATOR C0 WAS HIGH AT 29.56%. QC WERE PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES FROM 3MAR2021 UNTIL 6APR2021 EVEN IF THERE IS VARIATION ON THE QC LEVEL 1. ANALYSIS OF ARCHIVE DATA FILE DID NOT HIGHLIGHT ANY SPECIFIC ISSUE WITH CUSTOMER¿S ANALYZER. THE LOCAL SUPPORT WAS DISPATCHED AND PERFORMED A CARRYOVER TEST ON THE 16APR2021 AND IT WAS PASSING. A DIL TEST WAS ALSO PERFORMED, THE FIRST RESULT WAS 40.64 %CV IT WAS REPEATED WITH A 1.68 %CV. BOTH THE LUMIAP AND THE DIL-TEST WERE PASSING WITHIN SPECIFICATIONS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON THE (B)(6) 2021 TO ASSESS INSTRUMENT PERFORMANCE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636452 ACCESS 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER 15099590265380

    Patients

    Seq Age Sex Outcome Treatment
    1