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: 12215502 · Received July 22, 2021

    Report

    Report Number
    2243471-2021-02650
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 22, 2021
    Report Date
    September 1, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAD PREVIOUSLY INDICATED LAB CONTAMINATION THAT INCLUDES A CONTAMINATION OF SAFETY HOODS, BENCHES AND LIAT INSTRUMENTS. A REAGENT KIT INVESTIGATION WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. THERE IS INDICATION THAT THE DISCREPANT RESULTS ARE DUE TO SAMPLE SPECIFIC ISSUES OR LAB CONTAMINATION. THE QIASTAT-DX SARS-COV-2 RESPIRATORY PANEL LIMIT OF DETECTION (LOD) IS PUBLISHED AS 500 COPIES/ML WHERE THE LIAT SCFA ASSAY SARS-COV-2 ASSAY LOD IS PUBLISHED AS 12 COPIES/ML WHICH INDICATES A MUCH MORE SENSITIVE TEST. PLEASE NOTE, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. NO SYSTEM ISSUE OR PRODUCT PROBLEM IDENTIFIED. (B)(4).

    Additional Manufacturer Narrative · 0

    CUSTOMER HAD PREVIOUSLY INDICATED LAB CONTAMINATION THAT INCLUDES A CONTAMINATION OF SAFETY HOODS, BENCHES AND LIAT INSTRUMENTS. A REAGENT KIT INVESTIGATION WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. THERE IS INDICATION THAT THE DISCREPANT RESULTS ARE DUE TO SAMPLE SPECIFIC ISSUES OR LAB CONTAMINATION. THE QIASTAT-DX SARS-COV-2 RESPIRATORY PANEL LIMIT OF DETECTION (LOD) IS PUBLISHED AS 500 COPIES/ML WHERE THE LIAT SCFA ASSAY SARS-COV-2 ASSAY LOD IS PUBLISHED AS 12 COPIES/ML WHICH INDICATES A MUCH MORE SENSITIVE TEST. PLEASE NOTE, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. NO SYSTEM ISSUE OR PRODUCT PROBLEM IDENTIFIED. (B)(4).

    Additional Manufacturer Narrative · 0

    CUSTOMER HAD PREVIOUSLY INDICATED LAB CONTAMINATION THAT INCLUDES A CONTAMINATION OF SAFETY HOODS, BENCHES AND LIAT INSTRUMENTS. A REAGENT KIT INVESTIGATION WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. THERE IS INDICATION THAT THE DISCREPANT RESULTS ARE DUE TO SAMPLE SPECIFIC ISSUES OR LAB CONTAMINATION. THE QIASTAT-DX SARS-COV-2 RESPIRATORY PANEL LIMIT OF DETECTION (LOD) IS PUBLISHED AS 500 COPIES/ML WHERE THE LIAT SCFA ASSAY SARS-COV-2 ASSAY LOD IS PUBLISHED AS 12 COPIES/ML WHICH INDICATES A MUCH MORE SENSITIVE TEST. PLEASE NOTE, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. NO SYSTEM ISSUE OR PRODUCT PROBLEM IDENTIFIED. (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(6). A CUSTOMER FROM (B)(6) ALLEGED DISCREPANT RESULTS FOR FIVE PATIENTS WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. NO HARM WAS ALLEGED. A SYSTEMS ASSESSMENT BASED ON THE AVAILABLE DATA WAS PERFORMED AND NO SYSTEM ISSUE COULD BE FOUND. BOTH BACKGROUND AND BASELINE LEVELS OF THE ANALYZER WERE STABLE THROUGHOUT THE DATASET. THERE WAS CLEAR AMPLIFICATION FOR ALL ALLEGED RUNS, NOT MOTIVATED BY EITHER MOTION OR OPTICAL DISTURBANCES. ALL ALLEGATIONS WERE CONFIRMED AS TRUE POSITIVES. A REAGENT KIT INVESTIGATION HAS BEEN INITIATED AND IS ONGOING.

    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 (B)(6) ALLEGED DISCREPANT RESULTS FOR FIVE PATIENTS WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. ACCORDINGLY, 5 MDRS WILL BE FILED PER FDA GUIDANCE. PER CUSTOMER PROBLEM REPORT, ALL FIVE PATIENT SAMPLES INITIALLY TESTED POSITIVE FOR SARS-COV-2 ON THE LIAT SN (B)(4). THE SAME SAMPLES WERE RETESTED ON A DIFFERENT PLATFORM AND TESTED NEGATIVE FOR ALL TARGETS. THE CUSTOMER ALSO REPORTED THAT THEY NEEDED TO RECOLLECT SAMPLES FROM THE SAME PATIENTS AND RETEST THEM, HOWEVER, THE RESULTS OF THE RECOLLECTED SAMPLES WERE NOT REPORTED. THE POSITIVE RESULTS WERE RELEASED. NO HARM WAS ALLEGED. A SYSTEMS ASSESSMENT BASED ON THE AVAILABLE DATA WAS PERFORMED AND NO SYSTEM ISSUE COULD BE FOUND. A REAGENT KIT INVESTIGATION HAS BEEN INITIATED AND IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108551 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 01214Y

    Patients

    Seq Age Sex Outcome Treatment
    1