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: 12278642 · Received August 4, 2021

    Report

    Report Number
    2243471-2021-02818
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 6, 2021
    Report Date
    September 21, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR WAS SUBMITTED IN ERROR AND IS A DUPLICATE OF MDR 2243471-2021-02820. ONLY ONE SAMPLE WAS ALLEGED. (B)(4).

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED AND INDICATED THAT 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. A CUSTOMER ALLEGED A DISCREPANT SARS-COV-2 RESULT WHEN USING A COBAS ® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS ® LIAT ® SYSTEM, WHEN COMPARED WITH THE RESULTS GENERATED WITH THE GENEXPERT CEPHEID SYSTEM. THE INITIAL TEST GENERATED A SARS-COV-2 POSITIVE RESULT. THE SAME SAMPLE WAS REPEATED WITH THE GENEXPERT CEPHEID AND THE RESULT WAS NEGATIVE. THE NEGATIVE RESULT WAS RELEASED TO THE PATIENT AND OR/ MEDICAL PERSONNEL. NO HARM IS ALLEGED. THE CUSTOMER COLLECTED NASOPHARYNGEAL SAMPLE WITH MEDSCHENKER UTM 3M. FOR APPROVED COLLECTION KITS, THE METHOD SHEET STATES: THIS TEST IS INTENDED TO BE USED FOR THE DETECTION OF SARS-COV-2, INFLUENZA A AND INFLUENZA B RNA IN NASAL AND NASOPHARYNGEAL SWAB SAMPLES COLLECTED IN A COPAN UTM-RT SYSTEM (UTM-RT) OR BD¿ UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT) OR THERMO FISHER¿ SCIENTIFIC REMEL¿ MEDIA, OR THOMAS SCIENTIFIC MANTACC¿ PREMEASURED 3 ML 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULTS. PER THE FDA GUIDANCE THREE (3) MDRS WILL BE FILED, ONE (1) PER EACH PATIENT.. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175128 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 10405Y

    Patients

    Seq Age Sex Outcome Treatment
    1