BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG II

    MDR report key: 12636085 · Received October 14, 2021

    Report

    Report Number
    2122870-2021-00166
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    QKO
    UDI-DI
    15099590742744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, GENDER, WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGG II ASSAY WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF SYSTEM ISSUES AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF ISSUES WITH OTHER ASSAYS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. A 16.16 AU/ML COVID IGG II RESULT SHOULD BE INTERPRETED AS REACTIVE. THE ACCESS SARS-COV-2 IGG II REAGENT INSTRUCTIONS FOR USE (DOCUMENT C69158 A, AVAILABLE ON THE BECKMAN COULTER WEBSITE) RESULTS INTERPRETATION SECTION ADVISES A REACTIVE INTERPRETATION SHOULD BE USED WITH RESULTS =10 AU/ML. THE ROCHE ANTI-SARS-COV-2 S REAGENT INSTRUCTIONS FOR USE (ATTACHED) ADVISES THE ANALYTICAL MEASURE RANGE IS UP TO 2500 U/ML FOR A 10-FOLD DILUTION. RESULTS =0.80 U/ML ARE INTERPRETED AS POSITIVE FOR ANTI-SARS-COV-2-S. LOCAL SUPPORT OBSERVED THE CUSTOMER WAS USING EXPIRED REAGENT. THE IN-USE REAGENT PACK COVID IGG II LOT 124351 EXPIRED ON 30SEP2021. THE QUESTIONED COVID IGG II SAMPLE FLAGGED WITH CEX (CALIBRATION CURVE EXPIRED), LEX (REAGENT PACK LOT EXPIRED), AND PEX (OPEN PACK STABILITY EXPIRED) FLAGS. ALTHOUGH USE ERROR OF EXPIRED REAGENTS, CALIBRATOR, AND NO QUALITY CONTROL OCCURRED, USE ERROR CANNOT BE CONFIRMED AS THE CAUSE OF THIS EVENT. THE INTERPRETATION OF THE COVID IGG II RESULT ALIGNED WITH THE ROCHE METHODOLOGY. ADDITIONALLY, THERE WERE NO REPORTS OF THE CUSTOMER REPEATING THE SAMPLE ON UNEXPIRED REAGENT OR CALIBRATION CURVE. SARS-COV-2 IS AN ENVELOPED NON-SEGMENTED POSITIVE-SENSE RNA VIRUS. IT HAS SEVERAL STRUCTURAL PROTEINS INCLUDING SPIKE (S), ENVELOPE (E), MEMBRANE (M) AND NUCLEOCAPSID (N). THE SPIKE PROTEIN (S) CONTAINS A RECEPTOR BINDING DOMAIN (RBD) WHICH IS RESPONSIBLE FOR RECOGNIZING THE CELL SURFACE RECEPTOR, ANGIOTENSIN CONVERTING ENZYME-2 (ACE2). IT IS FOUND THAT THE RBD OF THE SARS-COV-2 S PROTEIN STRONGLY INTERACTS WITH THE HUMAN ACE2 RECEPTOR LEADING TO ENDOCYTOSIS INTO THE HOST CELLS AND VIRAL REPLICATION. THE ACCESS ASSAY DETECTS ANTIBODIES DIRECTED AGAINST THE SPIKE PROTEIN, WHICH ARE MORE LIKELY TO NEUTRALIZE THE VIRUS. NO MANUFACTURER GUARANTEES BOTH A SPECIFICITY AND SENSITIVITY OF 100%. THE CONCENTRATION OF SARS-COV-2 IGG IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS, DIVERSITY OF ANTIBODIES AND REAGENT SPECIFICITY. DIFFERENCES IN EACH INDIVIDUAL ASSAY ARE EXPECTED. DIFFERENT VACCINES DO NOT ELICIT THE SAME IMMUNE RESPONSE AND EACH PATIENT RESPONSE IS DIFFERENT THEREFORE DIFFERENCES IN PATIENT RESPONSES ARE EXPECTED AFTER VACCINATION. THE ACCESS ASSAY IS NOT LABELED FOR VACCINE RESPONSE DETECTION. ADDITIONALLY, PER SAFETY COMMUNICATION FROM FDA ON 19MAY2021, ANTIBODY TESTING IS NOT CURRENTLY RECOMMENDED TO ASSESS IMMUNITY AFTER COVID-19 VACCINATION. IN CONCLUSION, ALTHOUGH USE ERROR OF EXPIRED REAGENTS, CALIBRATOR, AND NO QUALITY CONTROL OCCURRED, USE ERROR CANNOT BE CONFIRMED AS THE CAUSE OF THIS EVENT. THE LIKELY CAUSE OF THIS EVENT IS USER EXPECTATIONS. THE COVID IGG II RESULT OF 16.16 AU/ML IS ASSOCIATED WITH A REACTIVE INTERPRETATION; THIS RESULT ALIGNS WITH RESULT RECOVERY ON THE ALTERNATE METHODOLOGY.

    Description of Event or Problem · 0

    ON 07OCTOBER2021 THE CUSTOMER REPORTED A QUESTIONED LOW COVID IGG RESULT (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124351) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, REFURBISHED, PART NUMBER 386220 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021 FOR A PATIENT WHO HAD BEEN PREVIOUSLY VACCINATED AGAINST COVID. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULT OF 16.16 AU/ML WAS RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2; THE PATIENT HAD RECEIVED A 2ND DOSE OF THE COVISHIELD VACCINE 15 DAYS PRIOR TO THE GENERATION OF THE RESULT OF 16.16 AU/ML. THE CUSTOMER REPORTED THE PATIENT DID NOT HAVE A HISTORY OF COVID INFECTION. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED A REACTIVE RESULT OF 1300 U/ML ON A ROCHE PLATFORM (THE ELECSYS ANTI-SARS-COV-2 S ASSAY). NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. IT WAS NOTED THAT THE CUSTOMER WAS USING AN EXPIRED CALIBRATION CURVE AT THE TIME OF THE EVENT. THE CUSTOMER WAS ALSO USING AN EXPIRED COVID REAGENT PACK AT THE TIME OF THE EVENT. THE CUSTOMER WAS NOT RUNNING QUALITY CONTROL AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531447 ACCESS SARS-COV-2 IGG II IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO BECKMAN COULTER 124351 15099590742744

    Patients

    Seq Age Sex Outcome Treatment
    1