BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST

    MDR report key: 11735686 · Received April 27, 2021

    Report

    Report Number
    2243471-2021-01043
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 28, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4)

    Additional Manufacturer Narrative · 0

    NEW INFORMATION OBTAINED REVEALED THAT THE CUSTOMER USED THE MAGNA PURE 96 EXTERNAL LYSIS BUFFER AS A SAMPLE TYPE. BLUE DROPLETS WERE OBSERVED IN THE TRANSFER MODULE DURING SAMPLE TRANSFER. THE USE OF MAGNA PURE 96 EXTERNAL LYSIS BUFFER (MATNR: 06 374 913 001) AS SAMPLE TYPE ON COBAS® 6800/8800 SYSTEMS FOR THE SARS-COV-2 ASSAY IS CONSIDERED TO BE OFF-LABEL. THE PIPETTING PARAMETERS VALIDATED FOR SARS-COV-2 ASSAY SAMPLE TYPES (SWAB AND COBAS PCR MEDIA SWAB) ARE NOT OPTIMIZED FOR THIS LIQUID TYPE. ADDITIONALLY THE LONG TERM EFFECT OF THE EXTERNAL LYSIS BUFFER USAGE AND OF THE INCREASE FOAM TENDENCY ON THE SYSTEM ARE CURRENTLY UNKNOWN. THE CUSTOMER ASKED ABOUT MUTATIONS, HOWEVER, MUTATION WOULD NOT BE THE CAUSE OF THE FALSE POSITIVE. A MUTATION MAY BE RESPONSIBLE FOR THE DIFFERENCE IN THE CT BETWEEN TARGET ONE AND TARGET TWO. NO MORE SAMPLE LEFTOVER FOR RETESTING, NO SEQUENCING WAS DONE. AS DISCREPANT RESULT WERE GENERATED AN INVESTIGATION WAS PERFORMED ON THE REAGENT LOT WHICH DID NOT IDENTIFY ANY PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION. (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 IN (B)(6) ALLEGED GENERATION OF DISCREPANT RESULTS FOR A PATIENT SAMPLE WHEN USING THE COBAS SARS-COV-2 TEST FOR USE ON THE COBAS 6800/8800 SYSTEM COMPARED TO OTHER TESTS. THE SAMPLE GENERATED A POSITIVE SARS-COV-2 RESULT WITH THE COBAS SARS-COV-2 TEST. THE FIRST REPEAT TEST OF THE ORIGINAL SAMPLE ON THE GENEXPERT (COMMERCIËLE KIT E-GENE AND N2) GENERATED NEGATIVE RESULTS FOR SARS ¿COV-2. THE SECOND REPEAT TEST OF THE SAME SAMPLE ON THE - ABI7500 FROM APPLIED BIOSYSTEMS (IN-HOUSE PCR ONLY E-GENE) GENERATED NEGATIVE RESULTS FOR SARS ¿COV-2. ONLY THE FINAL NEGATIVE RESULTS WERE RELEASED TO DOCTOR. NO HARM IS ALLEGED. THE INVESTIGATION IS ON-GOING AND A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626505 COBAS SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G28037

    Patients

    Seq Age Sex Outcome Treatment
    1