BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 - 480T

    MDR report key: 12527208 · Received September 24, 2021

    Report

    Report Number
    2243471-2021-03361
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 25, 2021
    Report Date
    December 3, 2021
    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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED WITH THE COMPLAINT KIT LOT DURING THE COURSE OF THE INVESTIGATION. A REVIEW OF THE DATA REVEALED THAT 1 SAMPLE WAS NEAR THE LIMIT OF DETECTION (LOD) OF THE TEST AND RAW DATA SHOWS ROBUST GROWTH CURVES. THE 2ND SAMPLE IS NOT NEAR THE LOD AND ALSO HAD ROBUST CURVES. BOTH OF THE SAMPLES ARE BEING COMPARED TO RESULTS GENERATED ON THE PD MAX SYSTEM, WHICH HAS DIFFERENT TARGETS THAN THE COBAS® SARS-COV-2 ASSAY. THIS DIFFERENCE IN TECHNOLOGY BETWEEN THE TWO TESTS IS A LIKELY CAUSE OF THE DISCREPANCY BEING ALLEGED. (B)(4).

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM THE AUSTRIA ALLEGED FALSE POSITIVE RESULT FOR 3 PATIENTS ON THE KIT COBAS 6800/8800 SARS-COV-2 480T AND ON THE COBAS 68/8800 SYSTEM. THE INITIAL TEST RESULT WAS POSITIVE FOR SARS-COV-2. THE SAMPLE WAS RESTED WITH A DIFFERENT PLATFORM AND COULD NOT BE CONFIRMED. A REVIEW OF THE DATA REVEALED THE 1ST SAMPLE WAS NEAR THE LIMIT OF DETECTION (LOD) AND RAW DATA SHOWS ROBUST CURVES. THE 2ND SAMPLE IS NOT NEAR THE LOD AND ALSO HAD ROBUST CURVES. DATA WAS ONLY AVALIABLE FOR 2 OUT OF THE 3 SAMPLES. AN INVESTIGATION TO EVALUATE THE CUSTOMER ISSUE IS ONGOING. (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 AUSTRIA ALLEGED FALSE POSITIVE RESULT FOR 3 PATIENTS ON THE KIT COBAS 6800/8800 SARS-COV-2 480T AND ON THE COBAS 68/8800 SYSTEM. THE INITIAL TEST RESULT WAS POSITIVE FOR SARS-COV-2. THE SAMPLE WAS RESTED WITH A DIFFERENT PLATFORM AND COULD NOT BE CONFIRMED. A REVIEW OF THE DATA REVEALED 1ST SAMPLE IS NEAR THE LIMIT OF DETECTION (LOD) AND RAW DATA SHOWS ROBUST CURVES. THE 2ND SAMPLE IS NOT NEAR THE LOD AND ALSO HAD ROBUST CURVES. FOR THE 3RD SAMPLE, NO SAMPLE ID OR THE DATA ARE AVAILABLE. LOD SAMPLES ARE EXPECTED TO WAIVER BETWEEN POSITIVE AND NEGATIVE UPON REPEAT. THE GROWTH CURVE IS ROBUST, AND IS INDICATIVE OF TRUE VIRAL AMPLIFICATION. IT IS LIKELY THE DISCREPANCY BETWEEN RESULTS IS DUE TO THE DIFFERENCE IN TECHNOLOGIES. ASSAYS CAN DIFFER IN SENSITIVITY AND THEIR ABILITY TO IDENTIFY VIRAL LOAD. AN INVESTIGATION TO EVALUATE THE CUSTOMER ISSUE IS ONGOING. PER THE FDA GUIDANCE, TWO (2) MDRS WILL BE FILED, ONE PER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423638 COBAS® SARS-COV-2 - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H04507

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown