BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG

    MDR report key: 12630932 · Received October 14, 2021

    Report

    Report Number
    2122870-2021-00165
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. NO LOT NUMBER WAS PROVIDED, NO EXPIRATION DATE, NO UDI, NO DEVICE MANUFACTURE DATE COULD BE PROVIDED. THE ACCESS SARS-COV-2 IGG REAGENT WAS NOT RETURNED FOR EVALUATION. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. 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 DETECT ANTIBODIES DIRECTED AGAINST THE SPIKE PROTEIN, WHICH ARE MORE LIKELY TO NEUTRALIZE THE VIRUS. 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. RESULTS OBTAINED WITH THE ACCESS ASSAY MAY NOT BE USED INTERCHANGEABLY WITH VALUES OBTAINED WITH DIFFERENT MANUFACTURERS¿ TEST METHODS. THERE IS NO INTERNATIONAL CONSENSUS DETERMINING THE PROTECTIVE ANTIBODY RESPONSE FOR SARS-COV-2. DUE TO THE LACK OF CLINICAL INFORMATION, NO FURTHER INVESTIGATION COULD BE PERFORMED. ALTHOUGH REQUESTED SEVERAL TIMES, THE CUSTOMER STATED THEY WERE UNDERSTAFFED AND WERE UNABLE PROVIDE ADDITIONAL INFORMATION. A BECKMAN COULTER APPLICATIONS SCIENTIST ANSWERED TO THE CUSTOMER DIRECTLY. THE CUSTOMER WAS SATISFIED WITH THE ANSWER AND DID NOT REPORT FURTHER ISSUES. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A REAGENT OR HARDWARE MALFUNCTION OCCURRED IN THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER NOT PROVIDED) RESULTS WERE GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 800 IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THEY OBTAINED NON-REACTIVE SARS-COV-2 IGG PATIENT RESULTS AT 0 S/CO ON (B)(6) 2021. RESULTS WERE DISCORDANT WITH AN UNKNOWN METHOD WHICH GENERATED REACTIVE RESULTS ON A SECOND SAMPLE FROM THE SAME PATIENT. IT IS UNKNOWN IF THE PATIENT HAD INITIALLY BEEN INFECTED OR VACCINATED. NO FURTHER INFORMATION WAS PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. NO SYSTEM CHECK, QUALITY CONTROL (QC) OR CALIBRATION DATA WAS PROVIDED. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. ALTHOUGH REQUESTED SEVERAL TIMES, THE CUSTOMER STATED THEY WERE UNDERSTAFFED AND WERE UNABLE PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534808 ACCESS SARS-COV-2 IGG IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO BECKMAN COULTER

    Patients

    Seq Age Sex Outcome Treatment
    1