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: 11070142 · Received December 23, 2020

    Report

    Report Number
    2243471-2020-00645
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 23, 2020
    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 · 1

    INVESTIGATION ON THE TWO REAGENT KITS LOT 00604Z AND 0616Z, USED BY THE CUSTOMER, DID NOT IDENTIFY ANY PRODUCT ISSUE. SOME RESULT RAW DATA WAS PROVIDED BUT NO SAMPLE IDS WERE PROVIDED. WITHOUT SAMPLE IDS, IT WAS NOT POSSIBLE TO IDENTIFY THE ALLEGED SAMPLES FOR DATA ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    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 IN THE US ALLEGED DISCREPANT RESULTS WHEN COMPARING THE ORIGINAL TEST AND RETEST RESULTS ON THE COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM, AND COMPARING WITH THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800/8800 SYSTEM. THE SAMPLES WERE NASOPHARYNGEAL SAMPLES COLLECTED WITH A VARIETY OF COLLECTION MEDIA MANUFACTURERS: BD, COPAN, BARTEL AND HARDY DIAGNOSTICS. THE PRODUCT'S INSTRUCTIONS FOR USE PROVIDES INFORMATION UNDER THE SECTION ADDITIONAL MATERIALS REQUIRED, NASOPHARYNGEAL SWAB COLLECTION KITS: FLEXIBLE MINITIP FLOQSWAB WITH UNIVERSAL TRANSPORT MEDIA (UTM®) FROM COPAN DIAGNOSTICS OR BD UNIVERSAL VIRAL TRANSPORT (UVT) 3-ML COLLECTION KIT WITH A FLOCKED FLEXIBLE MINITIP SWAB. REVIEW OF A SUMMARY OF DATA PROVIDED BY THE CUSTOMER SHOWED 12 SAMPLE DISCREPANCIES COMPARING THE ORIGINAL AND RETEST ON THE COBAS LIAT SYSTEM AND REST ON THE COBAS 6800 SYSTEM. RESULTS WERE REPORTED OUT. NO HARM WAS ALLEGED. INVESTIGATION ON THE TWO REAGENT KITS LOT 00604Z AND 0616Z, USED BY THE CUSTOMER, DID NOT IDENTIFY ANY PRODUCT ISSUE. TWELVE (12) MDRS, ONE PER EACH REPORTED RESULTS, WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534813 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 00604Z

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR