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: 11597188 · Received March 31, 2021

    Report

    Report Number
    2243471-2021-00614
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 18, 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

    INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION.(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 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).

    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.THE CUSTOMER ALLEGED DISCREPANT RESULTS FOR A PATIENT ON THE COBAS® SARS-COV-2 ASSAY.A CUSTOMER FROM THE UNITED STATES ALLEGED INVALIDS AND DISCREPANT RESULTS WERE OBSERVED FOR SAMPLES FROM ONE PATIENT GENERATED ON THE LIAT ANALYZER S/N (B)(4). ON (B)(6) 2021 THE ORIGINAL PATIENT SAMPLE WAS COLLECTED AND TESTED ON THE ABBOTT ID ANALYZER THAT GENERATED SARS-COV-2 NEGATIVE RESULTS. ON THE SAME DAY A RE-COLLECTION OF THE PATIENT SAMPLE WAS TESTED USING THE COBAS LIAT ANALYZER (S/N (B)(4)) THAT GENERATED SARS-COV-2 POSITIVE, INFLUENZA A/B NEGATIVE RESULTS. A SECOND RE-COLLECTION OF THE PATIENT SAMPLE COLLECTED ON THE SAME DAY WAS TESTED USING THE SAME LIAT ANALYZER(S/N (B)(4)) THAT GENERATED NEGATIVE RESULTS FOR ALL TARGETS. ON (B)(6) 2021 A REPEAT TEST ON BOTH SAMPLES 2 & 3 WAS TESTED ON THE SAME LIAT ANALYZER(S/N (B)(4)) BOTH SAMPLES GENERATED NEGATIVE RESULTS FOR ALL TARGETS.PATIENT SAMPLE WAS COLLECTED USING NASOPHARYNGEAL SWAB AND HAN-CHANG MEDIC MULTI-PURPOSE MEDIUM, 3 ML. THE CUSTOMER ALSO OBSERVED THAT SOME OPERATORS ADD TWICE THE AMOUNT OF SAMPLE TO THE ASSAY TUBE THAN IS CALLED FOR IN THE METHOD SHEET. 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 POSITIVE SARS-COV-2 TEST RESULT WAS REPORTED TO THE PHYSICIAN. NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE POSITIVE RESULT, NO ALLEGATIONS OF HARM, INJURY OR DANGER TO THE PATIENT.THE INVESTIGATION TO ASSESS THE CUSTOMER ALLEGATION HAS NOT YET BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494199 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 01008Y

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR