BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGM

    MDR report key: 11626418 · Received April 7, 2021

    Report

    Report Number
    9680746-2021-00031
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 7, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    UDI-DI
    15099590738617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE NUMBER OF QUESTIONED PATIENT SAMPLES WAS NOT PROVIDED. 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. "ASPIRATION MONITOR DETECTED POSSIBLE OBSTRUCTION" ERRORS OCCURRED JUST BEFORE THE EVENT. ALTHOUGH THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER, THIS ERROR MAY OCCASIONALLY OCCUR WITH SAMPLES WITH CLOTS AND FIBRINS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO ASSESS THE CUSTOMERS INSTRUMENT. THE PROCESSES, CALIBRATION, CONTROLS, SYSTEM CHECK AND DTEST WERE ANALYZED, ALL OF WHICH ARE WITHIN THE QUALITY SPECIFICATIONS. IT WAS NOT POSSIBLE TO ANALYZE AND REPEAT SAMPLES IN THE PACK IN QUESTION BECAUSE IT WAS USED UNTIL THE END. IN CONCLUSION, ALTHOUGH A PREANALYTICAL ISSUE IS SUSPECTED, IT COULD NOT BE VERIFIED AS THE CUSTOMER DID NOT REPORT ANY SPECIFIC ISSUE RELATED TO SAMPLE HANDLING. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON 18MAR2021 THE CUSTOMER REPORTED FALSE REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971287) RESULTS WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). CUSTOMER REPORTED RESULTS OUTSIDE OF THE LABORATORY AND RESULTS WERE QUESTIONED. WHEN THE CUSTOMER REPEATED THE SAMPLES ON DXI 800 SERIAL NUMBER (B)(4), THE RESULTS WERE NON-REACTIVE. THE EXACT NUMBER OF PATIENTS RESULTS QUESTIONED WAS NOT PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. CALIBRATION PASSED ON 18FEB2021 WITH REAGENT LOT 971287 AND CALIBRATOR LOT 922427. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORYS ESTABLISHED RANGES AT THE TIME OF THE EVENT. SYSTEM CHECK PASSED ON 15MAR2021. ON 17MAR2021 FROM 12:43 AM TO 01:16 AM, FOUR (4) "ASPIRATION MONITOR DETECTED POSSIBLE OBSTRUCTION" ERRORS OCCURRED JUST BEFORE THE EVENT. ALTHOUGH THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER, THIS ERROR MAY OCCASIONALLY OCCUR WITH SAMPLES WITH CLOTS AND FIBRINS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 24MARCH2021 TO ASSESS THE CUSTOMERS INSTRUMENT. THE PROCESSES, CALIBRATION, CONTROLS, SYSTEM CHECK AND DTEST WERE ANALYZED, ALL OF WHICH ARE WITHIN THE QUALITY SPECIFICATIONS. IT WAS NOT POSSIBLE TO ANALYZE AND REPEAT SAMPLES IN THE PACK IN QUESTION BECAUSE IT WAS USED UNTIL THE END. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, CENTRIFUGATION, STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527360 ACCESS SARS-COV-2 IGM IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO 971287 15099590738617

    Patients

    Seq Age Sex Outcome Treatment
    1