BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

    MDR report key: 11399018 · Received March 2, 2021

    Report

    Report Number
    2243471-2021-00431
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 2, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. (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 KNOWN POSITIVE SARS-COV2 REFERENCE SAMPLE. A CUSTOMER FROM (B)(6) ALLEGED ONE FALSE NEGATIVE RESULT WHEN TESTING A KNOWN POSITIVE SARS-COV2 REFERENCE SAMPLE ON THE COBAS ® SARS-COV-2 & INFLUENZA A/B ASSAY ANALYZED ON THE LIAT SYSTEM DURING A CORRELATION STUDY. ON (B)(6) 2021, DISCREPANT RESULT FOR A KNOWN POSITIVE SARS-COV REFERENCE SAMPLE, WHEN ANALYZED ON THE LIAT NEGATIVE RESULTS WERE REPORTED. THE AFFECTED SAMPLE IS A KNOWN WEAK POSITIVE SARS-COV-2 USED FOR CORRELATION STUDY IN PREPARATION FOR LAB ACCREDITATION. THE SAME SAMPLE WAS POSITIVE IN COMPETITOR GENEXPERT WITH A CT VALUE OF 41. THE SAMPLE WAS COLLECTED USING THROAT SALIVA IN 1:1 UTM. 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 INVESTIGATION TO ASSESS THE CUSTOMER ALLEGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295760 COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 00827Z

    Patients

    Seq Age Sex Outcome Treatment
    1