BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGM

    MDR report key: 10734514 · Received October 26, 2020

    Report

    Report Number
    9680746-2020-00042
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 26, 2020
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    UDI-DI
    15099590738617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILL PATIENT IDENTIFIER IS CASE(B)(6) . THE ACCESS SARS-COV-2 IGM REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. PER THE SARS-COV-2 IGM INSTRUCTIONS FOR USE (IFU), PART NUMBER (PN) C65791 C ¿SAMPLES SHOULD BE COLLECTED FROM INDIVIDUALS WITHIN 8 DAYS TO 30 DAYS POST SYMPTOM ONSET. SAMPLES SHOULD NOT BE TESTED LESS THAN 8 DAYS POST SYMPTOM ONSET. NEGATIVE SAMPLES COLLECTED FOR 8 DAYS POST SYMPTOM ONSET SHOULD BE REFLEXED TO DIRECT DETECTION OF THE VIRUS¿ AND ¿A NEGATIVE RESULT CAN OCCUR IF THE QUANTITY OF ANTIBODIES FOR THE SARS-COV-2 VIRUS PRESENT IN THE SPECIMEN IS BELOW THE DETECTION LIMIT OF THE ASSAY, OR IF THE VIRUS HAS UNDERGONE MINOR AMINO ACID MUTATION(S) IN THE EPITOPE RECOGNIZED BY THE ANTIBODY USED IN THE TEST.¿ IN CONCLUSION, ALTHOUGH A SEROCONVERSION IS SUSPECTED, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE QUANTITY OF ANTIBODIES FOR THE SARS-COV-2 VIRUS PRESENT IN THE SPECIMEN MAY BE BELOW THE DETECTION LIMIT OF THE ASSAYS. THE SAMPLE WHICH GENERATED A POSITIVE PCR WAS COLLECTED THE SAME DAY. A SUBSEQUENT SAMPLE MAY BE REQUIRED TO DETERMINE THE PATIENT¿S IMMUNE STATUS. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 1

    ON 08OCT2020 THE CUSTOMER REPORTED ONE NON-REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971217) RESULT WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (REFURBISHED) (PART NUMBER 386220 AND SERIAL NUMBER (B)(4)). THE ACCESS RESULT OF 0.28 S/CO (REPORTABLE RANGE: REACTIVE =1.0 S/CO) WAS OBTAINED ON (B)(6) 2020 AT 10:06 AM. THE PATIENT DID NOT PRESENT ANY SYMPTOM BUT HAD A POSITIVE PCR. THE SARS-COV-2 IGG RESULT WAS ALSO NON-REACTIVE (0.02 S/CO AT 10:00 AM). THE SAMPLE FOR PCR TESTING WAS COLLECTED THE SAME DAY AS THE SAMPLE FOR SEROLOGY TESTING. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2020 WITH REAGENT LOT 971217 AND CALIBRATOR LOT 922425. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON (B)(6) 2020. THERE WAS NO ISSUE WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. 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
    1197982 ACCESS SARS-COV-2 IGM IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO 971217 15099590738617

    Patients

    Seq Age Sex Outcome Treatment
    1