BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SYSTEM

    MDR report key: 11853026 · Received May 19, 2021

    Report

    Report Number
    2243471-2021-01368
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 21, 2021
    Report Date
    August 9, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE CONCLUSIONS ARE AVAILABLE. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS LIAT SYSTEM, PRODUCT CODE: OCC, CATALOG NUMBER 07341920692 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 ((B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST IS 07341920692 AND THE UDI IS (B)(4). (B)(4)

    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 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. ANALYZER WAS RETURNED AND WILL BE SENT TO THE REPAIR DEPOT FOR SERVICE. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER IN THE UNITED STATES REPORTED FALSE POSITIVE SARS-COV-2 AND FLU A RESULTS WERE GENERATED WHILE USING COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM (LOT 10125U, EXPIRATION DATE 31DEC2021, SERIAL NUMBER (B)(4)). DUE TO THE DUAL POSITIVE RESULTS BEING GENERATED, THE SAMPLE WAS RETESTED. THE SAME SAMPLE WAS RETESTED USING A DIFFERENT LIAT AND A CEPHEID AND GENERATED NEGATIVE RESULTS ON ALL THREE TARGETS. THE NEGATIVE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS COLLECTED USING COLLECTION KIT 3ML UTM MINI-TIP FLOCKED SYNTHETIC SWAP WITH PLASTIC BD 220529 LOT 2101508, EXPIRATION DATE 31JUL2022 NO HARM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743187 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 20 YR