BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 ¿ 480T

    MDR report key: 15015177 · Received July 14, 2022

    Report

    Report Number
    2243471-2022-00605
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 16, 2022
    Report Date
    July 14, 2022
    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
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER FDA GUIDANCE FOR EUA, A BATCH MDR IS BEING SUBMITTED TO REPRESENT ALL ALLEGED SAMPLES AS IT IS UNKNOWN WHICH RESULTS OF IF ANY RESULTS WERE REPORTED OUT. THE CONCLUSION IS THAT NO PRODUCT PROBLEM OR SYSTEMIC ISSUE WAS IDENTIFIED AND THE REASON FOR THE DIFFERENCES OBSERVED ARE SAMPLE SPECIFIC. ALTHOUGH CONTAMINATION IS PLAUSIBLE, HANDLING AND SITE SPECIFIC ISSUES CANNOT BE RULED OUT. A SYSTEM ASSESSMENT CONFIRMED THAT THERE WAS NO INDICATION OF CROSS CONTAMINATION. THE CUSTOMER PROVIDED DATA SHOWS THAT THE CURVE FOR THOSE SAMPLES ARE QUITE ROBUST INDICATING A POSITIVE SIGNAL. WHILE UNKNOWN, THE REASON FOR THE DISCREPANCIES OBSERVED BY THE CUSTOMER IS LIKELY SAMPLE SPECIFIC AS THE DATA DOES NOT SHOW ANY INDICATION OF A PRODUCT PROBLEM OR SYSTEMIC ISSUE. RELIABLE RESULTS DEPEND ON PROPER SAMPLE COLLECTION, STORAGE AND HANDLING PROCEDURES. IN ADDITION, THOUGH THE CUSTOMER DID NOT SPECIFY THE SAMPLE TYPE FOR THE TWO ALLEGED SAMPLES, IT WAS COMMUNICATED THAT MOST OF THE SAMPLES HANDLED BY THE LAB WERE SALIVA. THIS TEST IS INTENDED TO BE USED FOR THE DETECTION OF SARS-COV-2 RNA IN NASAL, NASOPHARYNGEAL, AND OROPHARYNGEAL SWAB SAMPLES COLLECTED IN A COPAN UTM-RT SYSTEM(UTM-RT) OR BD¿ UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT) AND NASAL SWAB SAMPLES COLLECTED IN COBAS® PCR MEDIA AND 0.9% PHYSIOLOGICAL SALINE. TESTING OF OTHER SAMPLE TYPES WITH COBAS®SARS-COV-2 MAY RESULT IN INACCURATE RESULTS. DETECTION OFSARS-COV-2 RNA MAY BE AFFECTED BY SAMPLE COLLECTION METHODS, PATIENT FACTORS (E.G PRESENCE OF SYMPTOMS), AND/OR STAGE OF INFECTION.

    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 FROM (B)(6) ALLEGED DISCREPANT RESULTS WITH TWO PATIENT SAMPLES WHILE USING THE COBAS SARS-COV-2 QUALITATIVE NUCLEIC ACID TEST FOR USE ON THE COBAS 6800/8800 SYSTEM. BOTH ALLEGED SAMPLES INITIALLY GENERATED A POSITIVE RESULT ON COBAS 6800 (TARGET 1 & 2 POSITIVE). THE SAME SAMPLES WERE RETESTED (ALIQUOT FROM THE SAME PRIMARY VIAL) ON COBAS 6800, ON COBAS LIAT AND ON A DIFFERENT PLATFORM (GENEXPERT). ALL GENERATED A NEGATIVE RESULT. IT IS UNKNOWN IF OR WHICH RESULTS WERE REPORTED OUT. NO HARM OR INJURY IS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426343 COBAS® SARS-COV-2 ¿ 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H36331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown