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: 12031211 · Received June 21, 2021

    Report

    Report Number
    2243471-2021-02066
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 20, 2021
    Report Date
    September 10, 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 IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    DATA ASSESSMENT INDICATED NO SIGNS OF SYSTEMATIC ISSUES WERE PRESENT ON ANY OF THE INSTRUMENTS. MOREOVER, THE CT VALUES GENERATED FOR THE RUNS ALLEGED ARE INDICATIVE OF SAMPLES NEARING OR BELOW THE LIMIT OF DETECTION (LOD) OF THE ASSAY. WAVERING RESULTS MAY OCCUR WITH SAMPLES NEAR OR BELOW THE LOD. (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED THE REAGENT LOT # IN AND SUBSEQUENTLY UPDATED THE EXPIRATION DATE. 1 SAMPLE USED LOT# 10222Y (MDR 2243471-2021-02064). 1 SAMPLE USED LOT# 10308Y (MDR 2243471-2021-02068). 2 SAMPLES USED LOT# 10308Z(MDR 2243471-2021-02065 AND THIS MDR). CORRECTED DEVICE CODE FROM FALSE POSITIVE RESULT TO NOT REPRODUCIBLE RESULTS (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 RESULTS GENERATED ON 4 PATIENT SAMPLES WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM WHEN COMPARED TO OTHER TESTING PLATFORMS. INITIAL SAMPLES GENERATED POSITIVE RESULTS FOR SARS-COV-2 WITH 3 OF THE COBAS® LIAT® SYSTEMS. THE NEW SAMPLES WERE RECOLLECTED AND REPEATED ON OTHER UNKNOWN TESTING PLATFORMS AND THE RESULTS WERE NEGATIVE. THE RESULTS WERE REPORTED TO THE PATIENTS. NO HARM IS ALLEGED. AN INVESTIGATION IS ONGOING. PER THE FDA GUIDANCE FOUR (4) MDRS WILL BE FILED ONE PER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929538 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 10308Z

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR