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: 12419240 · Received September 3, 2021

    Report

    Report Number
    2243471-2021-03173
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    July 16, 2021
    Report Date
    September 2, 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

    THE CUSTOMER'S COBAS LIAT ANALYZER (S/N (B)(4)) WAS RETURNED FOR EVALUATION AND REPAIR. FROM THE INSPECTION, IT WAS IDENTIFIED THAT A TUBE LEAKAGE OCCURRED DURING RUN #44, WHICH SIGNIFICANTLY IMPACT BOTH BACKGROUND AND BASELINE LEVELS OF THE ANALYZER, HINTING A POTENTIAL OPTICAL PATH OBSTRUCTION AND THE OBSERVED FALSE POSITIVE RESULTS. 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. THE IMPLEMENTATION OF BOTH THE SOFTWARE AND THE UPDATED SCRIPT HAVE SHOWN A REDUCTION IN THE CALCULATED FALSE POSITIVE RATE. 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 PRODUCT CODE QJR, CATALOG NUMBER 09211101190. (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FROM A COBAS® LIAT® SYSTEM (S/N (B)(4)). A CUSTOMER FROM THE UNITED STATES ALLEGED THAT THEY RECEIVED POTENTIAL FALSE POSITIVE RESULTS FOR 16 PATIENTS¿ SAMPLES WHEN TESTED WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY AND ANALYZED ON THE COBAS® LIAT® SYSTEM (S/N (B)(4)). THE CUSTOMER REPORTED THAT FROM THE DATES OF (B)(6) 2021 RUN #44 GENERATED AN INFLUENZA A POSITIVE RESULT FOR A PATIENT¿S SAMPLE AND RUNS #75, #89, #174, #185, #204, #211, #229, #241, #277, #304, #309, #321, #326, #351 & #355 EACH OF THE RUNS GENERATED INFLUENZA B POSITIVE RESULTS FOR 15 PATIENTS¿ SAMPLES. THE CUSTOMER REPORTED THAT SOME PATIENT SAMPLES WERE RECOLLECTED, RETESTED, USING THE INITIAL COLLECTION, UNKNOWN IF REPEAT TESTED ON COMPETITOR EUA PLATFORMS, THE SAME COBAS® LIAT® SYSTEM (S/N (B)(4)) OR A DIFFERENT COBAS® LIAT® SYSTEM. NO PATIENT DETAILS WERE MADE AVAILABLE, AND NO HARM OR INJURY WAS INDICATED. PATIENT SAMPLE WAS COLLECTED USING NASOPHARYNGEAL COLLECTED IN REMEL M4RT. THIS IS NOT A RECOMMENDED PRACTICE FOR SAMPLE COLLECTION. AS PER THE METHOD SHEET, COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND/OR STANDARD COLLECTION TECHNIQUE USING 3 ML OF VIRAL TRANSPORT MEDIA OR STERILE 0.9% PHYSIOLOGICAL SALINE. THE RESULTS WERE NOT REPORTED OUT TO THE PATIENTS AND/OR PERSONNEL TREATING THE PATIENTS. SIXTEEN (16) MDRS WILL BE FILED ONE FOR EACH SAMPLE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322426 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 10426Y

    Patients

    Seq Age Sex Outcome Treatment
    1