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: 11037993 · Received December 18, 2020

    Report

    Report Number
    2243471-2020-00525
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    November 26, 2020
    Report Date
    December 18, 2020
    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 · 1

    THROUGH THE COURSE OF THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE FACILITY NAME IS (B)(6). (B)(4).

    Description of Event or Problem · 1

    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 IN (B)(6) ALLEGED DISCREPANT RESULTS SEEN WITH THE COBAS SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE WITH THE COBAS LIAT SYSTEM (LOT 00827Z) WITH TWO (2) SAMPLES COLLECTED FROM THE SAME PATIENT. THE FIRST COLLECTION TAKEN FROM THE PATIENT WAS NEGATIVE WITH THE COBAS SARS-COV-2 & FLU TEST, WHILE THE SECOND COLLECTION WAS POSITIVE WITH BOTH THE COBAS SARS-COV-2 & FLU AND CEPHEID TESTS. THE AFFILIATE CONFIRMED THAT THIS SAMPLE WAS FROM AN OUTPATIENT CASE AND THE SAMPLE COLLECTION WAS A DEEP THROAT SALIVA (DTS) SPECIMENS. THE SAMPLES WERE TESTED WITHIN 30 MINUTES TO 1 HOUR AFTER COLLECTION. 200UL OF DTS IS RESUSPENDED IN 2ML OF UTM (BASO BRAND). THE SAMPLE COLLECTION AND PRE-TREATMENT ARE NOT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE COBAS SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM (COBAS SARS-COV-2 & INFLUENZA A/B) IS AN AUTOMATED MULTIPLEX REAL-TIMERT-PCR ASSAY INTENDED FOR THE SIMULTANEOUS RAPID IN VITRO QUALITATIVE DETECTION AND DIFFERENTIATION OF SARS-COV-2, INFLUENZA A, AND INFLUENZA B VIRUS RNA IN HEALTHCARE PROVIDER-COLLECTED NASOPHARYNGEAL AND NASAL SWABS AND SELF-COLLECTED NASAL SWABS (COLLECTED IN A HEALTHCARE SETTING WITH INSTRUCTION BY A HEALTHCARE PROVIDER) FROM INDIVIDUALS SUSPECTED OF A VIRAL RESPIRATORY INFECTION. THE POSITIVE RESULTS WERE REPORTED AFTER CONFIRMATION USING ANOTHER PLATFORM GENEXPERT AND SPECIMEN WAS SENT TO THE HEALTH AUTHORITY REFERENCE LABORATORY FOR FURTHER CONFIRMATION. NO HARM WAS REPORTED. THROUGH THE COURSE OF THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504307 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