BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 15080169 · Received July 21, 2022

    Report

    Report Number
    2024800-2022-01068
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 21, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, CUSTOMER REPORTED THAT THEY WERE STILL EXPERIENCING POSITIVE CONTAMINATION AFTER HOLOGIC SERVICED THE CUSTOMER¿S PANTHER INSTRUMENT SN (B)(4) ON (B)(6) 2022. BECAUSE CUSTOMER SUSPECTED THAT THERE WAS STILL CONTAMINATION, CUSTOMER DISCONTINUED THE USE OF THE INSTRUMENT AND DECIDED TO PERFORM ADDITIONAL INVESTIGATIONAL TESTING. CUSTOMER THEN ASKED HOLOGIC TO REVIEW LOGS FOR WORKLIST 003331-20220615-07. CUSTOMER USED ASSAY LOT 319624. THE WORKLIST CONTAINS 168 SAMPLES TESTED AND 39 WERE POSITIVE. HOLOGIC FIELD SERVICE ENGINEERS (FSE) WENT TO THE CUSTOMER SITE, PERFORMED A FULL PERFORMANCE QUALIFICATION (PQ) ON PANTHER INSTRUMENT SN (B)(4) AND PRODUCED THE EXPECTED RESULTS. HOLOGIC CONCLUDED THAT THE DISCREPANT RESULTS MAY HAVE POTENTIALLY BEEN DUE TO SAMPLE MISHANDLING, CROSS CONTAMINATION, THE PRESENCE OF A LOW TARGET, OR TARGET DEGRADATION DUE TO HANDLING AND STORAGE. FSE REPORTED THAT THE CUSTOMER FEELS CONFIDENT THAT THE MULTIPLE CLEANINGS HAVE RESOLVED THE ISSUE AND HAS CONTINUED USING THE PANTHER INSTRUMENT. NO PRODUCT IMPACT IS KNOWN TO DATE. A REVIEW OF THE LOGS DID NOT REVEAL INSTRUMENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115999 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC. 319624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown