BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SYSTEM

    MDR report key: 11592219 · Received March 30, 2021

    Report

    Report Number
    2243471-2021-00611
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    February 28, 2021
    Report Date
    April 27, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OCC
    PMA / PMN Number
    K111387
    Removal / Correction Number
    2243471-03-17-2021-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COBAS LIAT ANALYZER WAS RETURNED FOR EVALUATION AND REPAIR. THROUGH THE INVESTIGATION IT WAS NOTED THAT THERE WAS A TUBE LEAK THAT CAUSED A SHIFT IN BOTH BACKGROUND AND BASELINE LEVELS OF ALL CHANNELS, RESULTING IN THE TWO FALSE POSITIVE RESULTS.

    Additional Manufacturer Narrative · 0

    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 AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER IDENTIFY ERRORS AND DETECT ABNORMAL PCR CURVES WILL BE MADE AVAILABLE BETWEEN APRIL - JUNE 2021. CONSIGNEES HAVE BEEN NOTIFIED. 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). (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 IN (B)(6) REPORTED TWO FALSE POSITIVE TEST RESULTS GENERATED USING THE COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM. BOTH SAMPLES GENERATED POSITIVE RESULTS ON LIAT SN (B)(4). BOTH SAMPLES WERE REPEATED ON GENEXPERT FOLLOWED BY ANOTHER LIAT. FOR BOTH CASES, BOTH GENEXPERT AND LIAT PRODUCED NEGATIVE REPEAT RESULTS AND SAMPLE WAS REPORTED OUT AS NEGATIVE. SAMPLE 1 GENERATED POSITIVE SARS-COV-S RESULTS (CT-VALUE 30.4) USING NASOPHARYNGEAL SWAB (UTM BASO BRAND). THE SAMPLE WAS STORED AT ROOM TEMPERATURE AND TESTED WITHIN AN HOUR OF COLLECTION. SAMPLE 2 GENERATED POSITIVE SARS-COV-S RESULTS (CT-VALUE 34.4) USING 200 UL DEEP THROAT SALIVA WITH UTM (BASO BRAND). THE SAMPLE WAS STORED AT ROOM TEMPERATURE AND TESTED WITHIN AN HOUR OR TWO OF COLLECTION. THE PRODUCT IS STORED IN A 2-8OC FRIDGE. NO HARM IS ALLEGED. TWO MDRS WILL BE FILED FOR THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488012 COBAS LIAT SYSTEM RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM OCC ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR