BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 15199838 · Received August 10, 2022

    Report

    Report Number
    2024800-2022-01078
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    June 23, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER.

    Description of Event or Problem · 0

    ON (B)(6) 2022, HOLOGIC FIELD APPLICATION SPECIALIST (FAS) CALLED THE CUSTOMER TO FOLLOW UP ON A COMPLAINT ABOUT POSSIBLE CONTAMINATION WHEN TESTING WITH SARS-COV-2 ASSAY (ASARS). FAS STATED THAT THE CUSTOMER HAD AN ISSUE WITH A POSSIBLE CONTAMINATED ASARS TMA KIT THAT HAPPED AT THE BEGINNING OF JUNE. THE CASE WAS CLOSED, BUT THE CUSTOMER DECIDED TO GO THROUGH ALL THEIR WORKLISTS FROM THE PAST FEW MONTHS AND THEY FOUND ANOTHER POSSIBLY CONTAMINATED ASARS KIT THAT SEEMED TO HAVE HAD ISSUES. THE CUSTOMER EMPHASIZE THAT THEY ARE VERY CONCERNED THAT THERE IS AN ISSUE WITH THE ASARS TMA LOT USED OR A HARDWARE ISSUE. THE CUSTOMER ALSO MENTIONED THAT THEY ARE CONCERNED THAT FALSE RESULTS MAY HAVE BEEN REPORTED OUT. UPON FURTHER INVESTIGATION, THE CUSTOMER DETERMINED THAT THERE WERE OTHER RUNS THAT HAD A HIGHER-THAN-NORMAL POSITIVITY RATE WITH SOME SAMPLES HAVING LOW RLU VALUES. THE CUSTOMER UPLOADED LOGS FOR HOLOGIC TO REVIEW. ON (B)(6) 2022 THE CUSTOMER CALLED TS TO REPORT CONTINUED ISSUES WITH THE APTIMA SARS-COV-2 ASSAY LOT: 317818 AS THEY WERE EXPERIENCING LOW POSITIVE RESULTS. THE CUSTOMER REPORTED TESTING 2 SAMPLES FROM WORKLIST (B)(4) RESULTED POSITIVE FOR THE ASARS ASSAY WITH LOW RLUS, BUT WERE RE-TESTED NEGATIVE ON A DIFFERENT PANTHER INSTRUMENT. NO PRODUCT IMPACT IS KNOWN TO DATE. THE COMPLAINT RELATES TO A CONTAMINATION EVENT WHERE THERE WAS A CONTAMINATION WITH ONE CUSTOMER KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211252 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC. 317818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown