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: 12138245 · Received July 8, 2021

    Report

    Report Number
    2243471-2021-02358
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    2243471-03-17-2021-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS LINKED TO THE FOLLOWING MDRS WHICH WERE SUBMITTING FOLLOWING THE SAME CUSTOMER ALLEGATION FOR POTENTIAL FALSE POSITIVE RESULTS: 2243471-2021-02353-00 2243471-2021-02354-00 2243471-2021-02355-00 2243471-2021-02356-00 2243471-2021-02357-00 ONE ADDITIONAL RUN (#424) WAS IDENTIFIED DURING DATA REVIEW TO HAVE GENERATED A FALSE POSITIVE RESULT FOR INFLUENZA B WITH THE COBAS® LIAT® SARS-COV-2/FLU TEST DUE TO ABNORMAL BASELINE AND PHOTOMETER READINGS. THE ANALYZER WAS RETURNED AND WILL BE SENT TO THE REPAIR DEPOT FOR SERVICE. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS LIAT SYSTEM, PRODUCT CODE: OCC, CATALOG NUMBER 07341920190 AND UDI (B)(4). THE TEST USED ON THE COBAS LIAT SYSTEM IS THE COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM (EUA201779, PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST IS 09211101190 AND THE UDI IS (B)(4). ROCHE RECEIVED COMPLAINTS ALLEGING INVALID AND/OR FALSE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM FOR ONE OR MORE TARGETS (SARS-COV-2, INFLUENZA A, INFLUENZA B). WHEN REVIEWING THE CUSTOMER-PROVIDED DATA ASSOCIATED WITH THE REPORTED INVALID AND FALSE POSITIVE RESULTS, ABNORMAL PCR CURVES WERE OBSERVED. PER THE ON-GOING INVESTIGATION, SEVERAL POTENTIAL CAUSES FOR THE ABNORMAL PCR GROWTH CURVES LEADING TO INVALIDS AND FALSE POSITIVES HAVE BEEN IDENTIFIED. THESE INCLUDE TUBE LEAKS, ABNORMAL PCR STEPS, AND LOOSE THERMAL SENSOR WIRING. OVERALL ACROSS THE INSTALLED BASE, THESE ISSUES FROM PRODUCT USE MAY OCCUR SPORADICALLY. FOR INVALID OR FALSE POSITIVE INFLUENZA RESULTS, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY. FOR INVALID SARS-COV-2, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY SINCE DETECTABILITY IS HIGH AND TESTING CAN BE PERFORMED ON ALTERNATIVE PLATFORMS. FOR ERRONEOUS POSITIVE SARS-COV-2 RESULTS, THERE IS THE POSSIBILITY OF ADVERSE HEALTH CONSEQUENCES IN HIGH RISK INDIVIDUALS. AS STATED IN THE INSTRUCTIONS FOR USE, CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. A COBAS LIAT SOFTWARE UPDATE TO BETTER IDENTIFY THE THERMAL SENSOR ERRORS AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER DETECT ABNORMAL PCR CURVES HAVE BEEN LAUNCHED. CONSIGNEES HAVE BEEN NOTIFIED. (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. REVIEW OF THE PROVIDED DATA CONFIRMED THAT A CUSTOMER FROM THE US GENERATED A POTENTIAL FALSE POSITIVE RESULT FOR FLU B USING A COBAS® SARS-COV-2 AND INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029896 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 01214X

    Patients

    Seq Age Sex Outcome Treatment
    1