BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 12958595 · Received December 8, 2021

    Report

    Report Number
    2024800-2021-00047
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 7, 2021
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MOLECULAR TECHNICAL SUPPORT (MTS) REVIEWED THE LOGS WHICH SHOWED: FROM WORKLIST ID 003527-20211108-03, SARS TMA KIT (MLN 306139/TCR ID 05431): 17 POSITIVE RESULTS (567 - 1330 RLU). FROM WORKLIST ID 003527-20211109-03, SARS TMA KIT (MLN 306139/TCR ID 05297): 16 NEGATIVE RESULTS (307-521 RLU), 2 POSITIVE (678, 1341 ELU) AND 1 INVALID. THERE WAS NO HARDWARE ISSUE. MTS PROVIDED THE LOG REVIEW INFORMATION TO CUSTOMER AND CONFIRMED WITH THEM THAT ALL TESTS WERE PERFORMED ON NEW ALIQUOTS. TS EXPLAINED TO CUSTOMER THAT HOLOGIC CONSIDERS DIFFERENT ALIQUOTS AS DIFFERENT SAMPLES AND THEREFORE RESULTS CANNOT BE COMPARED. CUSTOMER CONFIRMED THEY ARE NOT AWARE OF ANY RECENT INCREASE IN POSITIVITY RATES OR POSITIVE ENVIRONMENTAL SAMPLES TS FOUND THAT CUSTOMER PLACED THE PENETRABLE CAPS WITH THREAD SIDE UP DURING SAMPLE ALIQUOTING IN THE SAFETY HOOD. CUSTOMER WILL CONSIDER LAYING THE CAPS ON THEIR SIDE TO PREVENT TOUCHPOINT CONTAMINATION OF THE FOIL CAP DURING SAMPLE PREPARATION. CUSTOMER AGREED TO CLEAN THE PREPARATION AREAS AND TOUCH POINTS WITH FRESH CLEANING SOLUTION AND WILL MONITOR THE SUBSEQUENT RUNS. CUSTOMER PERFORMED A MONTHLY MAINTENANCE ON THE INSTRUMENT, CLEANED THE SAMPLE PREPARATION AREA, PREPARED A NEW KIT, RAN 20 BLANK SAMPLE TUBES AND SOME SAMPLES AND THEY WERE SATISFIED WITH THE RESULTS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED 17 SAMPLES WERE INITIALLY TESTED POSITIVE WITH THE SARS-COV-2 ASSAY USING MASTER LOT 306139 ON THE PANTHER SN (B)(4). CUSTOMER RE-RAN THE AFFECTED SAMPLES ON THE GENEEXPERT INSTRUMENT, AND 15 SAMPLES WERE NEGATIVE AND 2 WERE POSITIVE. CUSTOMER RETESTED THE AFFECTED SAMPLES ON THE PANTHER, AND THEY WERE INVALID. TS ADVISED CUSTOMER TO HOLD-OFF REPORTING THE 17 SAMPLES UNTIL MTS CAN RETRIEVE AND REVIEW THE LOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859823 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 306139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown