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: 12170716 · Received July 14, 2021

    Report

    Report Number
    2243471-2021-02490
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 14, 2021
    Report Date
    September 17, 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 DID NOT IDENTIFY A PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION. IN CONCLUSION THE DISCREPANCIES WERE DUE TO THE SAMPLES BEING NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. GIVEN THE SAMPLES WERE RECOLLECTED, THE TIME FRAME BETWEEN THE COLLECTIONS MIGHT HAVE ALSO PLAYED A ROLE IN THE VIRAL CONCENTRATION PRESENT DURING THE RETEST OF THE SAMPLES. (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED REAGENT LOT NUMBER (AND SUBSEQUENT EXPIRATION DATE). 3 SAMPLES USED REAGENT LOT 10322X (REFLECTED IN MDRS 2243471-2021-02487, 2243471-2021-02488, 2243471-2021-02489), 1 SAMPLE USED REAGENT LOT 10329Y (NOW REFLECTED IN D4 OF THIS MDR) (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 GENERATED 4 POTENTIALLY DISCREPANT RESULTS WHEN USING A COBAS® SARS-COV-2 AND INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. ON (B)(6) 2021 THREE SAMPLES GENERATED SARS-COV-2 POSITIVE AND FLU A/B NEGATIVE. THREE (3) NEW SAMPLES WERE RECOLLECTED AND TESTED WITH ANOTHER COBAS® LIAT® SYSTEM, GENERATED NEGATIVE RESULTS. THE NEGATIVE RESULTS WERE RELEASED TO THE PATIENTS. NO PATIENT DETAILS WAS PROVIDED FOR THE REMAINING SAMPLE IN QUESTION. NO HARM IS ALLEGED. PER THE FDA GUIDANCE FOUR (4) MDRS WILL BE FILED ONE PER PATIENT. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063095 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 10329Y

    Patients

    Seq Age Sex Outcome Treatment
    1