BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    MDR report key: 12503109 · Received September 20, 2021

    Report

    Report Number
    2243471-2021-03325
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 1, 2021
    Report Date
    September 20, 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

    INVESTIGATION OF THE MATERIAL NUMBER DOES NOT INDICATE A PRODUCT PROBLEM. IT¿S IMPORTANT TO NOTE, THAT ADDITIONAL DATA WAS REQUESTED BUT NOT PROVIDED. AS SUCH, THE LIMIT OF DETECTION FOR GENEXPERT IS CLAIMED AT 0.0200 PFU/ML. THE SCFA PACKAGE INSERT INDICATES THAT THE COBAS® LIAT® SYSTEM SARS-COV-2 LOD IS 0.012 TCID50/ML WHICH CONVERTS TO 0.0084 PFU/ML, BEING OVER TWICE AS SENSITIVE AS THE GENEXPERT. THEREFORE, THE COBAS® LIAT SYSTEM WILL DETECT SARS-COV-2 WHEN THE VIRAL LOAD IS LOW, WHILE THE GENEXPERT REQUIRES A HIGHER VIRAL LOAD IN THE SAMPLE FOR DETECTION. ALTHOUGH NOT CONFIRMED DUE TO LACK OF DATA, THE ROOT CAUSE COULD BE FROM THE DIFFERENCE IN SENSITIVITY OF THE TWO ANALYZERS. (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 FROM THE US ALLEGED DISCREPANT PATIENT RESULTS WHEN USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM ANALYZER WHEN COMPARED TO THE RESULTS GENERATED BY THE GENEXPERT CEPHEID. ACCORDING TO THE CUSTOMER BETWEEN (B)(6) 2021 THE PATIENT SAMPLE GENERATED SARS-COV-2 POSITIVE ON 4 CONSECUTIVE TESTING ON THE COBAS® LIAT® ANALYZER. A NEW PATIENT SAMPLE WAS RECOLLECTED FOR THE FOURTH TEST AND TESTED ON THE GENEXPERT CEPHEID ANALYZER WAS SARS-COV-2 NEGATIVE. THE RESULTS WERE NOT REPORTED TO THE PATIENT AND OR/ MEDICAL PERSONNEL. NO HARM IS ALLEGED. ALTHOUGH THE PROBLEM REPORT WAS DELETED, ADDITIONAL DATA WAS REQUESTED FROM THE CUSTOMER, BUT WAS NOT PROVIDED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION. PER THE FDA GUIDANCE FOUR (4) MDRS WILL BE FILED, ONE (1) PER EACH SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400351 COBAS LIAT SARS-COV-2 & INFLUENZA A/B REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA #?

    Patients

    Seq Age Sex Outcome Treatment
    1