BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 14939058 · Received July 6, 2022

    Report

    Report Number
    2024800-2022-01025
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    March 23, 2022
    Report Date
    July 6, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND FOUND NO HARDWARE ISSUES; THEY INFORMED CUSTOMER OF DIFFERENT SENSITIVITIES OF THEIR ASSAYS. HOLOGIC SUBJECT MATTER EXPERT (SME) REVIEWED LOGS AND AGREED WITH TS¿S FINDINGS; THE PATTERN INDICATED A POSSIBLE POSITIVE CROSSOVER CONTAMINATION OF CONTROLS AND SAMPLES. THE ISSUE APPEARED TO BE ISOLATED TO THIS REAGENT KIT, BUT SAMPLE SHIELD CLEANING MAINTENANCE TASK WAS ALSO OVERDUE. ISSUE WAS RESOLVED WHEN A NEW REAGENT KIT WAS LOADED AND MONTHLY MAINTENANCE WAS PERFORMED. NO FURTHER ISSUES 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

    CUSTOMER REPORTED A POSSIBLE CONTAMINATION EVENT BASED ON AN OBSERVED INCREASE IN LOW POSITIVE SAMPLES FOR THEIR SARS-COV-2 TMA RUNS USING ASSAY LOT 317372. WL 003816-20220319-01 ON PANTHER INSTRUMENT SN (B)(4) WAS REVIEWED BY HOLOGIC TECHNICAL SUPPORT TO IDENTIFY ANY POTENTIAL CONTAMINATION. THE WL IN QUESTION WAS INVALID DUE TO ELEVATED RLUS ON THE NEGATIVE CONTROL. CUSTOMER TOOK NEW SWABS AND RETESTED ALL QUESTIONING POSITIVE SAMPLES USING THE ALINITY-ABBOT PLATFORM, WHERE ALL RESULTS WERE NEGATIVE. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. CORRECTIONS WERE MADE BY THE LAB TO RETEST ANY POSITIVE SAMPLE THEY QUESTIONED DURING THIS PERIOD. NO ADVERSE EVENTS WERE REPORTED, NOR UNNECESSARY TREATMENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046850 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC, INC. 317372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown