BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 ¿ 480T

    MDR report key: 14219857 · Received April 27, 2022

    Report

    Report Number
    2243471-2022-00444
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    March 3, 2022
    Report Date
    June 2, 2022
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA IS PENDING TO BE PROVIDED FOR REVIEW. AN INVESTIGATION WILL EVALUATE THE CUSTOMER ISSUE. A SUPPLEMENTAL MDR WILL BE SUBMITTED TO SHARE THE CONCLUSIONS. PER FDA GUIDANCE FOR EUA, A BATCH MDR IS BEING SUBMITTED TO REPRESENT ALL ALLEGED SAMPLES, AS THE INITIAL PRESUMPTIVE POSITIVE RESULTS WERE NOT REPORTED OUT. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 8800 SYSTEM (PRODUCT CATALOG NUMBER 05412722001; UDI: (B)(4); PMA 510K: BK140195; PRODUCT CODE: MZA). THE TEST USED ON THE COBAS 8800 SYSTEM IS THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800-8800 SYSTEM (EUA(B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST (480T) IS 09343733190 AND (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED B6 AND B5 TO REFLECT THAT THE RETESTS WERE PERFORMED ON THE SAME COBAS 8800 INSTRUMENT (INSTEAD OF A SEPARATE ONE AS STATED IN THE INITIAL MDR). NONE OF THE PROVIDED SAMPLE IDS COULD BE FOUND IN THE PROVIDED DATA. FROM THE PROVIDED DATA, ONE SAMPLE COULD BE IDENTIFIED THAT MATCHES THE ALLEGED PHENOMENON. HOWEVER, IT IS NOT KNOWN WHETHER THIS SAMPLE WAS RETESTED AND WHETHER THE RESULT OF RETESTING INDICATED A DISCREPANT RESULT. FROM THE SERVICE ACTIVITY REPORT FOR THE AFFECTED COBAS 8800 SYSTEM, IT COULD BE SEEN THAT THE HEAD PROCESSING TRANSFER FRONT WAS REPLACED, HOWEVER, THIS DID NOT SOLVE THE ISSUE. FURTHER ACTIVITY SHOWS THAT THE PUMP MICROGEAR ASSY WAS ALSO CHANGED. BASED ON THE SERVICE DOCUMENTATION, ALL POST REPAIR CHECKS WERE COMPLETED SUCCESSFULLY AND THE ISSUE DID NOT REOCCUR. THE ULTRASONIC DATA DID NOT SHOW ANY FLAGS WHICH ARE INDICATIVE OF LESS VOLUME PIPETTING BY THE MICROGEAR PUMP. FROM THE LOG FILES PROVIDED, NO SYSTEM RELATED ISSUE HAS BEEN IDENTIFIED. SINCE THE CORRESPONDING DATA FOR THE ALLEGED SAMPLE IDS WAS NOT MADE AVAILABLE, NO FURTHER INVESTIGATION OF THE OBSERVED ISSUE COULD BE CARRIED OUT. THE REPLACED PUMP MICROGEAR ASSY WAS ALSO NO LONGER AVAILABLE FOR FURTHER INVESTIGATION UPON REQUEST. DUE TO THE LACK OF CORRESPONDING DATA FOR THE ALLEGED SAMPLES, AND THE RELEVANT REPLACED PARTS, NO FURTHER INVESTIGATION WAS POSSIBLE. THUS, THE ALLEGED ISSUE FOR THIS CASE CANNOT BE CONFIRMED. (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 UNITED STATES ALLEGED DISCREPANT RESULTS FOR 7 PATIENT SAMPLES WHILE USING THE COBAS® SARS-COV-2 QUALITATIVE ASSAY FOR USE ON THE COBAS® 6800/8800 SYSTEMS. THE ALLEGED SAMPLES WERE TESTED ON COBAS 8800 AND INITIALLY GENERATED A PRESUMPTIVE POSITIVE RESULT (TARGET 1 NEGATIVE, TARGET 2 POSITIVE). THE SAME SAMPLES WERE RETESTED ON ANOTHER COBAS 8800 WHICH YIELDED A NEGATIVE RESULT FOR BOTH TARGETS (TARGET 1 & 2 NEGATIVE). THE INITIAL PRESUMPTIVE POSITIVE RESULTS WERE NOT RELEASED, ONLY THE NEGATIVE RESULTS WERE. NO HARM WAS ALLEGED. AN INVESTIGATION WILL EVALUATE THE CUSTOMER ISSUE. PER FDA GUIDANCE FOR EUA, A BATCH MDR IS BEING SUBMITTED TO REPRESENT ALL ALLEGED SAMPLES.

    Description of Event or Problem · 0

    THE SAME SAMPLES WERE RETESTED ON THE SAME COBAS 8800 WHICH YIELDED A NEGATIVE RESULT FOR BOTH TARGETS (TARGET 1 & 2 NEGATIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971369 COBAS® SARS-COV-2 ¿ 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown