BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 16306402 · Received February 6, 2023

    Report

    Report Number
    2024800-2023-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 6, 2023
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE RUN IN QUESTION, CUSTOMER INSPECTED THE INSTRUMENT AND DISCOVERED THE SAMPLE SHIELD WAS NOT PROPERLY PLACED, CAUSING THE PIPETTE TIP TO DRAG AND POTENTIALLY CONTAMINATE SAMPLES IN THIS RUN. CUSTOMER REMOVED THE CONTAMINATED SHIELD, BLEACHED IT, AND REPLACED IT WITH A NEW ONE. HOLOGIC TECHNICAL SUPPORT (TS) ADVISED THE CUSTOMER TO ALSO CLEAN THE TOUCH POINTS AROUND THE PANTHER, THEN RUN THE SAME REAGENT KIT USING BLANK SAMPLES TO ENSURE THE KIT WAS NOT CONTAMINATED. CUSTOMER RAN NEGATIVES AND ENVIRONMENTAL SAMPLES USING THE SAME KIT AS INSTRUCTED BY TS, AND ALL RESULTS WERE NEGATIVE. CUSTOMER RERAN THE AFFECTED SAMPLES ON A NON-HOLOGIC PLATFORM BUT DID NOT INFORM HOLOGIC OF THE RESULTS. NO FURTHER ISSUES WERE REPORTED. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL APTIMA SARS-COV-2 ASSAY QUESTIONING RESULTS AND FALSE RESULTS (CONFIRMED OR NOT) COMPLAINTS TO BE REPORTED AS MALFUNCTION MDR.

    Description of Event or Problem · 0

    HOLD FOR RH 2.6 CUSTOMER REPORTED POSITIVE CONTAMINATION IN ONE SARS-COV-2 TMA RUN USING ASSAY LOT 323084 ON PANTHER INSTRUMENT SN (B)(4). THE WORKLIST IN QUESTION, WL 001972-20230130-04, HAD 24 POSITIVE SAMPLES OUT OF 31 SAMPLES TESTED, SO CUSTOMER QUESTIONED THE VALIDITY OF THESE RESULTS. CUSTOMER INSPECTED THE INSTRUMENT AND DISCOVERED THE SAMPLE SHIELD WAS NOT PROPERLY PLACED, CAUSING THE PIPETTE TIP TO DRAG AND POTENTIALLY CONTAMINATE SAMPLES IN THIS RUN. CUSTOMER REMOVED THE CONTAMINATED SHIELD, BLEACHED IT, AND REPLACED IT WITH A NEW ONE. CUSTOMER ALSO DECIDED TO RETEST THE AFFECTED SAMPLES USING A NON-HOLOGIC PLATFORM. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. CUSTOMER DID NOT INFORM HOLOGIC OF ANY RESULTS BEING REPORTED TO PATIENTS OR ANY PATIENT IMPACT. THERE WERE NO ASSOCIATED/REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494987 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC, INC. 323084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown