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: 12305138 · Received August 10, 2021

    Report

    Report Number
    2243471-2021-02918
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 1, 2021
    Report Date
    September 28, 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

    DATA REVIEW INDICATED THAT THE POSITIVE RUNS FOR PATIENTS 3 AND 4 SHOWED LATE CTS AND WEAK AMPLIFICATION, CONSISTENT WITH SAMPLES THAT ARE NEAR THE LIMIT OF DETECTION (LOD) FOR THE COBAS® LIAT® TEST. THEREFORE THE RESULTS ARE EXPECTED TO WAVER UPON REPEAT. AS NO DATA WAS FOUND FOR PATIENTS 1 AND 2, THE CAUSE OF THE DISCREPANT RESULTS COULD NOT BE DETERMINED. POTENTIAL FACTORS COULD INCLUDE: - LOW TITER SAMPLE: RESULTS FOR SAMPLES WITH TITERS NEAR THE LIMIT OF DETECTION FOR A GIVEN TEST WILL WAIVER BETWEEN POSITIVE AND NEGATIVE. IN THIS CASE, THE SAMPLE WAS RETESTED ON DIFFERENT PLATFORMS, WHICH COULD ALSO POTENTIALLY GIVE DISCREPANT RESULTS, DUE TO DIFFERENCES IN METHOD SENSITIVITIES. - ABNORMAL PCR GROWTH: AN ISSUE RELATED TO SBN-RDS-MOLECULAR LAB-2021-005 COULD CAUSE A FALSE POSITIVE CALL, DUE TO DISTURBANCES IN THE AMPLIFICATION CURVE. ADDITIONAL INFORMATION IS AVAILABLE IN SBN-RDS-MOLECULAR LAB-2021-005 V2 AND QN-RMD-2021-003. - MUTATION: DIFFERENT METHODS MAY TARGET DIFFERENT REGIONS OF THE VIRAL DNA (LIAT AND GENEXPERT TARGET DIFFERENT REGIONS). MUTATION IN THE TARGET REGION COULD RESULT IN THE TARGET NOT BEING DETECTED - CONTAMINATION OR NON-SPECIFIC AMPLIFICATION: CROSS-CONTAMINATION DURING SAMPLE PREP COULD INTRODUCE THE TARGET INTO A NEGATIVE SAMPLE. IN SOME CASES, SAMPLE INTERFERENCES/CONTAMINANTS COULD CAUSE AMPLIFICATION OF SOMETHING OTHER THAN THE TARGET. (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED D4 REAGENT LOT NUMBER TO NI. NO DATA WAS FOUND FOR SAMPLE 1 THEREFORE THE REAGENT LOT COULD NOT BE IDENTIFIED. CN-620561.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. THE ANALYZER SERIAL # (B)(4) WAS RETURNED DUE TO INITIALIZATION FAILURES. (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 FROM THE US ALLEGED DISCREPANT RESULTS GENERATED ON 4 PATIENT SAMPLES WHEN USING A COBAS® SARS-COV-2 AND INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM, WHEN COMPARED TO THE RESULTS GENERATED WITH GENEXPERT CEPHEID FOR 1 OF THE SAMPLES . (B)(6) 2021: INITIAL SAMPLE ONE AND TWO GENERATED- SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B POSITIVE. THE SAME SAMPLE #1 WAS REPEATED ON THE COBAS® LIAT® SN (B)(4), AND GENERATED SARS-COV-2 NEGATIVE, FLU A NEGATIVE AND, FLU B POSITIVE. WHILE SAMPLE #2 WAS REPEATED ON BOTH THE COBAS® LIAT® SN (B)(4) AND GENERATED NEGATIVE RESULTS FOR ALL THE 3 TARGETS. AFTER CONSULTING THE PHYSICIAN ABOUT THE DISCREPANT RESULTS FOR SAMPLE #2, A NEW SAMPLE WAS COLLECTED AND TESTED IN THE MICRO LAB (UNKNOWN PLATFORM) GENERATED FLU B NEGATIVE. (B)(6) 2021, SAMPLE 3 GENERATED SARS-COV-2 DETECTED FLU A NEGATIVE AND FLU B NEGATIVE, THE PHYSICIAN AND THE NURSE QUESTIONED THE RESULTS SINCE THE PATIENT WAS FULLY VACCINATED AND SHOWED NO SYMPTOMS. A NEW SAMPLE WAS COLLECTED AND TESTED ON THE GENEXPERT CEPHEID AND WAS NEGATIVE, THE INITIAL SAMPLE WAS AGAIN REPEATED ON THE COBAS® LIAT® SN (B)(4), ALSO WAS NEGATIVE FOR ALL THE 3 TARGETS. (B)(6) 2021 SAMPLE 4 GENERATED SARS-COV-2 POSITIVE, FLU A NEGATIVE AND FLU B NEGATIVE, THE RESULT WAS REPORTED TO THE PHYSICIAN WHO STATED THAT THE PATIENT WAS ASYMPTOMATIC. THE SAME SAMPLE WAS REPEATED ON THE COBAS® LIAT® SN (B)(4). THE TWO RESULTS WERE BOTH NEGATIVE FOR ALL THE 3 TARGETS. ALL THE NEGATIVE RESULTS WERE REPORTED TO THE PATIENT AND MEDICAL PERSONNEL. NO HARM IS ALLEGED. AN INVESTIGATION IS ONGOING. PER THE FDA GUIDANCE FOUR (4) MDRS WILL BE FILED, ONE (1) PER EACH SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200266 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 10405Y

    Patients

    Seq Age Sex Outcome Treatment
    1