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: 11609898 · Received April 2, 2021

    Report

    Report Number
    2243471-2021-00628
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    February 7, 2021
    Report Date
    June 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) THIS CASE (CN-(B)(4)) INVOLVES AN ALLEGATION OF HARM FROM AN ALLEGED FALSE POSITIVE (FP) SARS-COV-2 TEST RESULT (PATIENT 1) OBTAINED USING AN OFF-LABEL MEDIA COLLECTION DEVICE (GLY MEDIUM (MEDIAPRODUCTS ¿ EWC DIAGNOSTICS) WITH COBAS LIAT SARS-COV-2 & INFLUENZA A/B (REFERRED TO HEREAFTER AS LIAT). THE PATIENT INVOLVED WAS A (B)(6) YEAR OLD MALE WITH LIKELY METABOLIC SYNDROME AND CARDIOVASCULAR DISEASE WITH PRESUMED AND EXISTING CONGESTIVE HEART FAILURE WHO PRESENTED TO THE HOSPITAL IN ACUTE RESPIRATORY DISTRESS AND REPORTED ACUTE HEART FAILURE. BASED ON THE ALLEGED FP, THE CUSTOMER REPORTS THAT THE PATIENT WAS QUARANTINED, PUT ON A VENTILATOR AND TREATED FOR COVID-19 WITH DEXAMETHASONE AND PROPHYLACTIC ANTICOAGULATION. SUBSEQUENT REPEAT TESTING APPROXIMATELY 1 WEEK INTO THE ADMISSION OF THE ORIGINAL SPECIMEN (UNKNOWN PLATFORMS, POSSIBLY GENEXPERT AND/OR PANTHER) AND ANTIBODY TESTING WERE NEGATIVE AND THE ORIGINAL LIAT RESULT WAS THEN THOUGHT TO BE FALSELY POSITIVE. THE PATIENT RECOVERED ENOUGH TO BE RELEASED FROM THE HOSPITAL. IN THIS CASE, AND BASED ON THE INFORMATION PROVIDED, LIAT TESTING WAS PERFORMED USING AN OFF-LABEL TRANSPORT MEDIA (GLY MEDIUM MEDIAPRODUCTS - EWC DIAGNOSTICS), WHICH CAN INDEPENDENTLY LEAD TO ERRONEOUS RESULTS. ANALYSIS OF THIS SAMPLE RUN DID SUGGEST THAT THE RESULT WAS A FALSE POSITIVE WITH AN ABNORMAL PCR GROWTH CURVE THAT WAS RELATED TO AN OPEN INVESTIGATION OF PCR INCOMPLETE TRANSFER (PIT). SINCE NO EVIDENCE WAS PROVIDED TO SUGGEST A DEFINITIVE COVID-19 INFECTION AT THE TIME OF HOSPITAL PRESENTATION, IT APPEARS THAT THE FP RESULT COULD HAVE LED TO AN INAPPROPRIATE CLINICAL DECISION TO QUARANTINE THE PATIENT AND TREAT FOR COVID-19 INFECTION WITH STEROIDS AND ANTICOAGULATION, BOTH OF WHICH ARE GENERALLY WELL TOLERATED. IT IS IMPORTANT TO NOTE THAT THERE WAS NO MENTION OF INFECTION, BLEEDING, HYPERGLYCEMIA OR OTHER COMPLICATIONS THAT CAN OCCUR DUE TO ADMINISTRATION OF STEROIDS AND/OR ANTICOAGULATION, RESPECTIVELY. WITH RESPECT TO THE NEED FOR MECHANICAL VENTILATION, IT IS MORE LIKELY THAT THE SEVERITY OF RESPIRATORY DISTRESS AND CONGESTIVE HEART FAILURE WERE THE PRIMARY DRIVERS AND NOT THE PRESENCE OF COVID-19 INFECTION. MOST PATIENTS WITH COVID-19 INFECTION DO NOT REQUIRE MECHANICAL VENTILATION AND THE DECISION TO INTUBATE IS GUIDED BY CLINICAL PRESENTATION. IN THIS CASE, IT ALSO APPEARS THAT THE PATIENT WAS SUCCESSFULLY DISCHARGED FROM THE HOSPITAL WITH A PRESUMED RECOVERY OF ACUTE RESPIRATORY DISTRESS. IN AGGREGATE, THIS CASE INVOLVES AN ERRONEOUS POSITIVE LIAT RESULT FOR SARS-COV-2 THAT MAY LIKELY HAVE LED TO AN INAPPROPRIATE DECISION TO QUARANTINE AND TREAT THE PATIENT FOR COVID-19 WITH STEROIDS AND ANTICOAGULATION. HOWEVER, THE PROBABILITY OF HARM RESULTING FROM THESE CLINICAL DECISIONS IS NOT LIKELY. 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). (B)(4)

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED WITH THE COMPLAINT KIT LOTS DURING THE INVESTIGATION. THE CUSTOMER USED 3 KITS LOTS (01116Y,01029Z, AND 01118Z) FOR TESTING PURPOSES: 3 SAMPLES USED 01116Y, 1 SAMPLE USED 01029Z, AND ONE SAMPLE USED 01118Z. (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 ALLEGED DISCREPANT RESULTS FOR 5 PATIENTS WHILE USING COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. PATIENT 1 GENERATED A POSITIVE SARS-COV-2 WHICH WAS RELEASED, BUT LATER REPLACED BY REPEAT NEGATIVE TESTING. PATIENT 2 GENERATED A POSITIVE SARS-COV-2 RESULT WHICH WAS RELEASED. IT IS UNKNOWN WHETHER THERE WAS REPEAT TESTING FOR THIS PATIENT. PATIENT 3 GENERATED A POSITIVE SARS-COV-2 RESULT WHICH WAS RELEASED AND CONSISTENT WITH CLINICAL SYMPTOMS. OTHER PLATFORMS GENERATED NEGATIVE RESULTS. PATIENT 4 GENERATED A POSITIVE RESULT FOR ALL TARGETS BUT ONLY THE NEGATIVE REPEAT TEST RESULTS WERE RELEASED. PATIENT 5 GENERATED A POSITIVE SARS-COV-2 AND FLU B RESULT WHICH WAS QUESTIONED AND NOT RELEASED. IT IS UNKNOWN WHETHER THERE WAS REPEAT TESTING FOR THIS PATIENT.ACCORDING TO THE CUSTOMER, SAMPLES WERE COLLECTED USING DISPOSABLE SAMPLING SWABS PROVIDED BY (B)(6). THIS NOT CONSIDERED A RECOMMENDED PRACTICE.PER FDA GUIDANCE, 5 MDRS WILL BE FILED, ONE PER DISCREPANT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505030 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 01116Y

    Patients

    Seq Age Sex Outcome Treatment
    1