BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 ¿ 480T

    MDR report key: 14287834 · Received May 5, 2022

    Report

    Report Number
    2243471-2022-00459
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 5, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FACILITY NAME: (B)(6) HOSPITAL CO. LTD. INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    THE CONCLUSION IS THAT NO PRODUCT PROBLEM OR SYSTEMIC ISSUE WAS IDENTIFIED AND THE REASON FOR THE DIFFERENCES OBSERVED ARE SAMPLE SPECIFIC. BASED ON THE INVESTIGATION PERFORMED AND THE DATA PROVIDED THERE IS NO INDICATION THE PRODUCT IS NOT PERFORMING AS INTENDED. ALTHOUGH UNKNOWN, THE DISCREPANCY ALLEGED IS LIKELY DUE TO SAMPLE OR SITE SPECIFIC FACTORS LIKE CONTAMINATION OR THE OFF-LABEL SAMPLE TYPE (PATIENT 1'S NASOPHARYNGEAL COLLECTION IS NOT RECOMMENDED WITH THE COBAS PCR MEDIA), AS THE SAMPLE GENERATED RESULTS INDICATIVE OF A SAMPLE NEAR THE LIMIT OF DETECTION. REMOVED PATIENT INFORMATION AS THE INFORMATION PROVIDED IN THE INITIAL MDR ONLY APPLIES TO PATIENT 1. PATIENT INFORMATION FOR PATIENT 2 AND 3 IS UNKNOWN. SPECIFIED IN B6 THAT THE NASOPHARYNGEAL SAMPLE COLLECTION TYPE ONLY APPLIES TO PATIENT 1. COLLECTION TYPE FOR PATIENT 2 AND 3 IS UNKNOWN. SPECIFIED THAT INFORMATION INCLUDED IN B7 ONLY APPLY TO PATIENT 1. ADDED THAT THE PATIENT INFORMATION (AGE, SEX) PERTAINS TO PATIENT 1 ONLY. CHANGED DEVICE CODE FROM FALSE NEGATIVE RESULT TO NON REPRODUCIBLE RESULTS.

    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 FROM THAILAND ALLEGED DISCREPANT RESULTS FOR THREE PATIENTS WHILE USING THE COBAS SARS-COV-2 QUALITATIVE NUCLEIC ACID TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS. SAMPLE 1 TESTED WEAKLY POSITIVE ON THE RAPID ANTIGEN TEST ON (B)(6) 2022. ON THE SAME DAY, THE SAMPLE WAS TESTED ON THE COBAS 6800 AND GENERATED NEGATIVE RESULTS FOR BOTH TARGET 1 AND TARGET 2. A NEW SAMPLE WAS COLLECTED AND TESTED ON THE COBAS 6800 AND GENERATED A POSITIVE RESULT FOR BOTH TARGET 1 AND TARGET 2. SAMPLE 2 TESTED POSITIVE ON THE RAPID ANTIGEN TEST. ON (B)(6) 2022, THE SAMPLE WAS TESTED ON THE COBAS 6800 AND GENERATED NEGATIVE RESULTS FOR BOTH TARGET 1 AND TARGET 2. A NEW SAMPLE WAS RECOLLECTED AND TESTED ON THE COBAS 6800 AND GENERATED NEGATIVE RESULTS ONCE AGAIN. SAMPLE 3 TESTED POSITIVE ON THE RAPID ANTIGEN TEST. ON (B)(6) 2022, THE SAMPLE WAS TESTED ON THE COBAS 6800 AND GENERATED A NEGATIVE RESULT FOR TARGET 1 AND A POSITIVE RESULT FOR TARGET 2. THE SAME SAMPLE WAS REPEATED ON THE COBAS 6800 AND GENERATED NEGATIVE RESULTS FOR BOTH TARGET 1 AND TARGET 2. A NEW SAMPLE WAS RECOLLECTED AND TESTED ON THE COBAS 6800 AND GENERATED A POSITIVE RESULT FOR BOTH TARGET 1 AND TARGET 2. THE RESULTS WERE REPORTED OUT. NO HARM HAS BEEN REPORTED TO-DATE. AN INVESTIGATION IS ONGOING. PER FDA¿S EUA GUIDANCE, 3 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177405 COBAS® SARS-COV-2 ¿ 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H36598

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female