BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 - 480T

    MDR report key: 12685585 · Received October 22, 2021

    Report

    Report Number
    2243471-2021-03584
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 22, 2021
    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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED ON THE REAGENT KIT LOT AND NO PRODUCT PROBLEM WAS IDENTIFIED. BASED ON THE INFORMATION AND DATA PROVIDED AND THE INVESTIGATION PERFORMED THERE IS NO INDICATION THE PRODUCT IS NOT FUNCTIONING AS INTENDED. THE COMPLAINT ALLEGATION WAS NOT OBSERVED. (B)(4).

    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. THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FOR THE KIT COBAS 6800/8800 SARS-COV-2 480T. A CUSTOMER FROM (B)(6) ALLEGED THAT THEY RECEIVED POTENTIAL FALSE NEGATIVE RESULTS FOR A CONFIRMED POSITIVE SARS PATIENT WHEN TESTED WITH THE KIT COBAS 6800/8800 SARS-COV-2 480T. THE CUSTOMER REPORTED THAT ON (B)(6) 2021 THEY OBSERVED A SARS-COV-2 POSITIVE RESULT FOR A PATIENT¿S SWAB SAMPLE WHEN ANALYZED ON THE COBAS® LIAT® SYSTEM. THE PATIENT¿S SAME SWAB SAMPLE WAS REPEAT TESTED, ANALYZED ON THE COBAS® 6800 THAT GENERATED A SARS-COV-2 NEGATIVE RESULT. ON (B)(6) 2021 A SECOND RECOLLECTED SWAB SAMPLE FROM THE PATIENT WAS ANALYZED ON THE COBAS® 6800 THAT GENERATED A SARS-COV-2 NEGATIVE RESULT, A SALIVA SAMPLE COLLECTED FROM THE PATIENT WAS TESTED, ANALYZED ON THE COBAS® 6800 THAT GENERATED A SARS-COV-2 NEGATIVE RESULT. ON SEPTEMBER 24, 2021 A THIRD RECOLLECTED SWAB SAMPLE FROM THE PATIENT WAS TESTED, ANALYZED ON THE COBAS® LIAT® SYSTEM THAT GENERATED A SARS-COV-2 POSITIVE RESULT, THE SAME SWAB SAMPLE WHEN ANALYZED ON THE COBAS® 6800 GENERATED A SARS-COV-2 NEGATIVE RESULT. PATIENT¿S SAMPLE WAS COLLECTED USING LABTURBO¿ SPECIMEN COLLECTION KIT THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF HARM TO THE PATIENT. THE RESULTS WERE REPORTED OUT TO THE PATIENT AND/OR PERSONNEL TREATING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580107 COBAS SARS-COV-2 - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H00366

    Patients

    Seq Age Sex Outcome Treatment
    1