BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 14704879 · Received June 15, 2022

    Report

    Report Number
    2024800-2022-01003
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    July 15, 2022
    Report Date
    July 15, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PERFORMED THE REQUIRED CLEANING. THE LOGS REVEALED THAT ALL CONTROL, ENVIRONMENTAL, AND BLANK RLUS WERE IN THE EXPECTED RANGE. THE CUSTOMER ALSO STATED THAT THEY SWITCHED TO CAPPED WORKFLOW FOR SARS-COV-2 ON (B)(6) 2022 TO AVOID ANY POTENTIAL CONTAMINATION. NO FURTHER ISSUES HAVE BEEN REPORTED TO TS CONCERNING THIS CASE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER CALLED HOLOGIC TECHNICAL SUPPORT (TS) TO REPORT DISCREPANT APTIMA SARS-COV-2 RESULTS. THE CUSTOMER INDICATED THAT ON (B)(6) 2022, THEY OBSERVED LOW RLUS IN THE 700S FOR 67 SAMPLES FROM MULTIPLE WORKLISTS. THE CUSTOMER RERAN 10 OF THESE SAMPLES ON (B)(6) 2022 WITH A NEW APTIMA SARS-COV-2 KIT (SAME LOT) AND OBTAINED 5 POSITIVE AND 5 NEGATIVE RESULTS. CUSTOMER ONLY PROVIDED 5 APTIMA SARS-COV-2 WORKLISTS FOR HOLOGIC TO REVIEW, WITH 1 DISCREPANT RESULT FROM EACH WORKLIST. THIS REPORT IS FOR (B)(6). 1 SAMPLE'S INITIAL RESULT IS POSITIVE, RETEST IS NEGATIVE USING ASSAY LOT 319059 ON THE PANTHER INSTRUMENT SN (B)(4). THE OTHER 4 WORKLISTS WILL BE REPORTED AS 4 SEPARATE MDRS. THE CUSTOMER'S REMAINING POSITIVE SAMPLES WERE SENT TO THEIR ACCOUNT¿S SISTER FACILITY AND WERE RERUN ON A DIFFERENT PANTHER INSTRUMENT SN (B)(4). THIS ACCOUNT OBTAINED 25/57 NEGATIVE RESULTS. THE CUSTOMER CONFIRMED, BUT DID NOT PROVIDE FURTHER INFORMATION TO HOLOGIC, THAT RETESTING WAS DONE USING THE ORIGINAL TUBES FROM THE INITIAL TESTING. CUSTOMER NOTED THAT OVERALL, 30/67 SAMPLES THAT ORIGINALLY TESTED POSITIVE FOR SARS-COV-2, RESULTED NEGATIVE UPON RETESTING. THE CUSTOMER CONFIRMED THAT RESULTS FOR THE 30 SAMPLES THAT WERE INITIALLY REPORTED AS POSITIVE WERE LATER CORRECTED AND REPORTED AS NEGATIVE TO THE PHYSICIAN THE FOLLOWING DAY AFTER RETESTING WAS COMPLETED. THE CUSTOMER IS NOT AWARE IF ANY TREATMENT WAS PROVIDED. PRODUCT APPLICATION SPECIALISTS (PAS) REVIEWED THE LOGS WHICH DID NOT REVEAL ANY REAGENT OR INSTRUMENT ISSUES. PAS RECOMMENDED THAT THE CUSTOMER PERFORM CLEANING OF THE LAB BENCHES AND TOUCH POINTS AND PERFORM A RUN WITH 50 BLANKS. PAS NOTED THAT IT IS DIFFICULT TO DETERMINE IF THESE WERE LOW POSITIVE SAMPLES THAT DID NOT REPEAT UPON RETESTING OR IF THE SAMPLES WERE MISHANDLED/CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408614 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC. 319059
    910405 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC. 319059

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown