BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI SARA-COV-2 RT-PCR

    MDR report key: 11988725 · Received June 12, 2021

    Report

    Report Number
    3004102403-2021-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2021
    Date of Event
    May 1, 2021
    Report Date
    June 12, 2021
    Manufacturer
    OPTI MEDICAL SYSTEMS, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA200215
    Removal / Correction Number
    Z-2310-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OPTI MEDICAL SYSTEMS SENT A NOTICE TO CUSTOMERS BASED ON DISCUSSIONS WITH FDA INDICATING THAT USERS OF OPTI SARS-COV-2 RT PCR TEST THAT A CENTRIFUGATION STEP IS NECESSARY TO PREVENT FALSE POSITIVIES WHEN USING OUR PCR TEST.

    Description of Event or Problem · 0

    OF THE 21 POSITIVE SAMPLES CORRELATES 100% WITH PREVIOUS RESULTS. OUT OF 19 NEGATIVE PATIENT'S SAMPLES, 2 SAMPLES CAME OUT POSITIVES WITH HIGH CT VALUES (36.0 AND 41.84 RESPECTIVELY). AN EXPLANATION OF ONE OF THE DISCREPANCIES, THE ONE WITH THE HIGH CT VALUE COULD BE A CONTAMINATION ISSUE. THE DISCREPANCIES OBTAINED WHEN VALIDATING THIS ASSAY CAN DEPEND ON THE SENSITIVITY OF EACH METHODOLOGY, THE PLATFORM USED AND THE REAGENTS USED TO TEST THESE SAMPLES.

    Description of Event or Problem · 1

    OF THE 21 POSITIVE SAMPLES CORRELATES 100% WITH PREVIOUS RESULTS. OUT OF 19 NEGATIVE PATIENT'S SAMPLES, 2 SAMPLES CAME OUT POSITIVES WITH HIGH CT VALUES (36.0 AND 41.84 RESPECTIVELY). AN EXPLANATION OF ONE OF THE DISCREPANCIES, THE ONE WITH THE HIGH CT VALUE COULD BE A CONTAMINATION ISSUE. THE DISCREPANCIES OBTAINED WHEN VALIDATING THIS ASSAY CAN DEPEND ON THE SENSITIVITY OF EACH METHODOLOGY, THE PLATFORM USED AND THE REAGENTS USED TO TEST THESE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885203 OPTI SARA-COV-2 RT-PCR COVID 19 MOLECULAR DIAGNOSTIC TEST QJR OPTI MEDICAL SYSTEMS, INC. 99-57003

    Patients

    Seq Age Sex Outcome Treatment
    1