BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 15204781 · Received August 10, 2022

    Report

    Report Number
    2024800-2022-01082
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    August 10, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER WAS INFORMED ON HOW TO AVOID CONTAMINATION OF NEGATIVE CONTROLS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED FALSE POSITIVES RESULTS WERE OBSERVED IN NEGATIVE CONTROL SAMPLES WHEN RUNNING SARS COV-2 ASSAY ON THE PANTHER INSTRUMENT. HOLOGIC TECHNICAL SUPPORT (TS) NOTED THAT THESE ARE INTERNALLY PREPARED SAMPLES, BUT THERE IS NO INFORMATION GIVEN ON OF THE FORMULATION (E.G. WATER, SPECIMEN TRANSPORT MEDIA ETC.), OR HOW THEY ARE PREPARED. THE CUSTOMER REPORTED THAT 7/688 OF THEIR INTERNALLY PREPARED NEGATIVE CONTROL SAMPLES HAVE RETURNED A FALSE POSITIVE RESULT. THERE IS NO SPECIFIC MENTION IN THE COMPLAINT OF ANY CONFIRMED CLINICAL FALSE POSITIVE CASES. THE ALLEGED 7 FALSE-POSITIVE NEGATIVE CONTROL RESULTS COULDN¿T BE CONFIRMED BY HOLOGIC AS THE DATA FILES PROVIDED BY THE CUSTOMER DIDN¿T LINE UP EXACTLY WITH WHAT WAS REPORTED BY THE CUSTOMER IN THE COMPLAINT RECORD. HOLOGIC TECHNICAL SUPPORT (TS) NOTED THAT BECAUSE THE CUSTOMER ONLY BELIEVES THEY REPORTED FALSE-POSITIVE RESULTS BY RUNNING NEGATIVE CONTROLS, IT IS NOT 100% CERTAIN THAT FALSE-POSITIVE RESULTS WERE REPORTED OUT. MOLECULAR APPLICATION SPECIALIST (MAS) CONTACTED THE CUSTOMER DISCUSSED THEIR WORKFLOW. HOLOGIC REVIEW OF WORKLIST (B)(4) USING MASTER LOT 317372 SHOWED 1 SUSPECTED FALSE POSITIVE RESULT. THERE IS NO KNOWN PRODUCT IMPACT TO DATE. IT WAS NOTED THAT SEVERAL DIFFERENT MASTER LOTS HAVE BEEN USED WHERE FALSE POSITIVE RESULTS ARE SUSPECTED, THEREFORE PRODUCT IS UNLIKELY TO BE THE CAUSE. THERE IS ALSO NO INDICATION FROM THE CUSTOMER OR TECHNICAL SUPPORT THAT THE CAUSE IS PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381565 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC. 317372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown