BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST

    MDR report key: 11447693 · Received March 9, 2021

    Report

    Report Number
    2243471-2021-00483
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    February 1, 2021
    Report Date
    March 9, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    HAS BEEN CORRECTED TO INDICATE THAT THE PRODUCT IS NOT A SINGLE USE PRODUCT.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED 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. (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 FOR A PATIENT ON THE COBAS® SARS-COV-2 ASSAY.A CUSTOMER FROM (B)(6) ALLEGED DISCREPANT RESULTS WITH A SINGLE PATIENT WHO HAD BEEN DIAGNOSED WITH MENINGOENCEPHALITIS WITHOUT ANY OTHER VIRUS FOUND. THE PATIENT WAS TESTED WITH SARS COV-2 ASSAY THAT GENERATED A POSITIVE RESULT. ON (B)(6) 2021 THE FIRST PATIENT SAMPLE WAS COLLECTED AND TESTED USING THE COBAS SARS COV-2 ASSAY AND ANALYZED ON THE COBAS 6800/8800 SYSTEMS THAT GENERATED A POSITIVE RESULT. WHEN REPEAT TESTING OF THE PATIENT SAMPLE WAS DONE WITH A NON-ROCHE TEST AND A NEGATIVE RESULT WAS GENERATED, IT IS UNKNOWN IF A RECOLLECTED SAMPLE OR SAME SAMPLE WAS USED FOR THE REPEAT TESTING. THERE IS ALSO AN UNKNOWN TIME DIFFERENCE BETWEEN THE INITIAL AND SECOND COLLECTION OF THE SAMPLE.PATIENT SAMPLE WAS CEREBROSPINAL FLUID COLLECTED FROM THE PATIENT. CEREBROSPINAL FLUID IS NOT CONSIDERED A RECOMMENDED PRACTICE FOR SAMPLE COLLECTION. AS PER THE METHOD SHEET, COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND/OR STANDARD COLLECTION TECHNIQUE USING 3 ML OF VIRAL TRANSPORT MEDIA OR STERILE 0.9% PHYSIOLOGICAL SALINE.THE RESULTS WERE REPORTED TO THE PATIENT OR MEDICAL PERSONNEL TREATING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343060 COBAS SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G29320

    Patients

    Seq Age Sex Outcome Treatment
    1