BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 16455584 · Received February 28, 2023

    Report

    Report Number
    2243471-2023-00142
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    February 2, 2023
    Report Date
    February 28, 2023
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY CAUSE FOR THE DISCREPANCY OBSERVED IS DUE TO THE SAMPLE HAVING A LOW VIRAL LOAD, EITHER FROM A PATIENT WITH A LOW TITER OR FROM LAB CROSS-CONTAMINATION, AND SAMPLE-TO-SAMPLE VARIABILITY. ACCORDING TO THE DATA PROVIDED AND REVIEWED, THE INSTRUMENT APPEARS TO BE WORKING WELL. THROUGHOUT THE DATA ANALYSIS, A SYSTEMATIC ISSUE WAS NOT OBSERVED AND A PRODUCT PROBLEM WAS NOT FOUND. ALL SAMPLES WITH POSITIVE RESULTS ARE AT THE LIMIT OF DETECTION (LOD) FOR THE ASSAY WHERE RESULTS ARE KNOWN TO WAIVER UPON REPEAT TESTING ACCORDING TO EXPECTED STATISTICAL VARIANCES IN DETECTION. IT IS POSSIBLE THAT A LOW LEVEL OF LABORATORY CONTAMINATION COULD CAUSE A LOW VIRAL LOAD IN THE SAMPLE. IN ADDITION, SAMPLE-TO-SAMPLE VARIABILITY CAN BE DUE TO: WHEN THE SAMPLE WAS COLLECTED IN RELATION TO THE DISEASE COURSE (PRE-SYMPTOMATIC, OR AS INFECTION DESCENDS TO LUNGS/OR PATIENT RECOVERS); HOW THE SAMPLE WAS STORED PRIOR TO TESTING (SAMPLE DEGRADATION); VARIANCES IN SAMPLE COLLECTION.

    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. UNDER THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER FROM JAPAN ALLEGED A DISCREPANT RESULT FOR THREE PATIENTS WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLES INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 (NEGATIVE FOR INFLUENZA A/B). A NEW SAMPLE WAS USED FOR EACH RETEST FOR EACH PATIENT. THE FIRST RETEST WAS DONE WITH A RAPID ANTIGEN TEST (QUICKNAVI-COVID-19 AG, DENKA COMPANY LTD) AND GENERATED A NEGATIVE SARS-COV-2 RESULT. THE SECOND RETEST WAS DONE WITH THE SAME COBAS LIAT AND GENERATED NEGATIVE RESULTS FOR ALL TARGETS. NOTE, PATIENT 2 WAS RETESTED ONCE MORE ON THE SAME COBAT LIAT AND GENERATED NEGATIVE RESULTS FOR ALL TARGETS. THE NEGATIVE RESULTS WERE REPORTED. NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 3 MDRS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626178 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20621U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown