BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SYSTEM

    MDR report key: 11704381 · Received April 21, 2021

    Report

    Report Number
    2243471-2021-00897
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 23, 2021
    Report Date
    June 15, 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

    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 IN DUE COURSE. CONSIGNEES HAVE BEEN NOTIFIED. (B)(4)

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COBAS LIAT ANALYZER WAS RETURNED FOR EVALUATION AND REPAIR. 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 IN DUE COURSE. 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 ((B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST IS 09211101190 AND THE UDI IS (B)(4). DEVICE RETURNED TO MANUFACTURER (FROM NO TO YES). REMOVED BIOCOMPATIBILITY PROBLEM IDENTIFIED FROM DEVICE EVALUATION CODE (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FROM THE COBAS LIAT SYSTEM (S/N (B)(4)). A CUSTOMER FROM THE UNITED STATES, (B)(6) ALLEGED FALSE POSITIVE RESULTS FOR TWO PATIENT SAMPLES USING THE COBAS® SARS-COV-2 & INFLUENZA A/B ASSAY GENERATED ON THE COBAS LIAT SYSTEM (S/N (B)(4)). ON (B)(6) 2021 THE CUSTOMER REPORTED THAT THEY RECEIVED SARS-COV-2 NEGATIVE INFLUENZA A NEGATIVE, INFLUENZA B POSITIVE RESULTS FOR TWO PATIENTS. THE CUSTOMER SENT THE PATIENTS¿ SAMPLES (SAME SAMPLE) OUT FOR RETESTING ON A DIFFERENT PLATFORM (PLATFORM USED UNKNOWN) THAT GENERATED SARS-COV-2 NEGATIVE INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULTS FOR PATIENT 1. FOR PATIENT 2 ONLY A SARS-COV-2 TEST WAS ORDERED, INFLUENZA A/B RETESTING WAS NOT PERFORMED. THE RESULTS GENERATED FOR PATIENT¿S 2 RETESTED SAMPLE (SAME SAMPLE) WAS SARS-COV-2 NEGATIVE. PATIENT SAMPLE WAS COLLECTED USING SWAB PLACED IN MEDIA NON-VALIDATED MEDIA, TYPE OF MEDIA NOT PROVIDED. 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. THERE WAS NO ALLEGATION OF HARM TO THE PATIENT. TEST RESULTS WERE NOT REPORTED TO EITHER PATIENT BUT REPORTED TO THE PERSONNEL TREATING THE PATIENTS. 2 MDRS WILL BE FILED ONE FOR EACH OF THE SAMPLES RESULTS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601102 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