BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 ¿ 480T

    MDR report key: 15252561 · Received August 18, 2022

    Report

    Report Number
    2243471-2022-00712
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 18, 2022
    Report Date
    September 7, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO PRODUCT ISSUE WAS IDENTIFIED. ALTHOUGH THE ROOT CAUSE CANNOT BE CONFIRMED, IT CAN BE CONCLUDED THAT THE CONTRIBUTING FACTOR IS LIKELY SAMPLE/SITE SPECIFIC. POSSIBLE CONTRIBUTING FACTORS ARE POOR COLLECTION, POOR SAMPLING OF PRIMARY SAMPLE TO SECONDARY TUBE, OR CONTAMINATION. DEVICE CODE UPDATED TO A090806 - TEST RESULT - NON REPRODUCIBLE FROM A090804 - FALSE POSITIVE RESULT. CORRECTED RETEST DATE FOR PATIENT 1 FROM 21 JUL TO 19 JUL, SPECIFIED INITIAL TEST FOR PATIENT 1 WAS OVERNIGHT 18TH INTO THE 19TH.

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER FROM THE UNITED STATES ALLEGED DISCREPANT RESULTS FOR THREE PATIENTS WHILE USING THE COBAS SARS-COV-2 TEST FOR USE ON THE COBAS 68/8800 SYSTEMS. THE ALLEGED SAMPLES INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 AND PAN-SARBECOVIRUS. THE SAME SAMPLES WAS RETESTED ON THE SAME COBAS 6800 AND GENERATED NEGATIVE RESULTS FOR BOTH TARGETS. PATIENT/SAMPLE 1 WAS RECOLLECTED AND TESTED ON A DIFFERENT PLATFORM (CEPHEID) WHICH YIELDED A NEGATIVE RESULT. THE INITIAL POSITIVE RESULTS WERE RELEASED. NO HARM WAS ALLEGED. PER FDA¿S EUA GUIDANCE, 3 MDRS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370637 COBAS® SARS-COV-2 ¿ 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA J01387

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown