BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 15033473 · Received July 15, 2022

    Report

    Report Number
    2024800-2022-01053
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 2, 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

    CUSTOMER PERFORMED THE REQUIRED CLEANING. MEDICAL SCIENCE LIAISON (MSL) INDICATED THAT THE CUSTOMER IS SATISFIED WITH THE PERFORMANCE OF THE INSTRUMENT AND ASSAY AND NOTED THAT SINCE MOVING TO THE CAPPED WORKFLOW, AND OTHER ADJUSTMENTS RECENTLY, THAT THEY HAVE NOT HAD ANY FURTHER CONCERNS. THE CUSTOMER HAS DECIDED TO SETUP THEIR OWN CUTOFFS FOR POSITIVES (RLU 750) AND REPEATS (RLU 750-900) WHICH WAS DISCUSSED WITH MSL TO BE OFF-LABEL.

    Description of Event or Problem · 0

    ON 06/02/2022, 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. 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 OF THE 5 POTENTIALLY IMPACTED WORKLIST FROM PANTHER SN (B)(4). THIS REPORT IS FOR WL (B)(4). THE RUN HAS 16 SPECIMEN TESTED, 2 POSITIVES. CUSTOMER USED ASSAY LOT 318345. NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS SPECIFIC WL, BESIDES PROVIDING THE WL FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057382 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC. 318345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown