COBAS® SARS-COV-2 & INFLUENZA A/B

Description of Event or Problem

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 TAIWAN ALLEGED DISCREPANT RESULTS FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED NEGATIVE RESULTS FOR SARS-COV-2, INFLUENZA A, AND INFLUENZA B. THE SAME SAMPLE WAS RETESTED ON THE SAME COBAS® LIAT® SYSTEM WHICH YIELDED A POSITIVE RESULT FOR SARS-COV-2 AND A NEGATIVE RESULT FOR INFLUENZA A AND INFLUENZA B. THE POSITIVE RESULT WAS RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION IS IN PROGRESS TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 1 MDR WILL BE FILED.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION. FACILITY NAME: THE FACILITY'S FULL NAME "(B)(6) LABORATORIES LTD (B)(6) LABORATORIES" HAS BEEN TRUNCATED DUE TO CHARACTER LIMITATIONS.

Additional Manufacturer Narrative

THE ANALYZER IS PERFORMING STABLE AND AS EXPECTED FOR THE WHOLE DATASET. THERE IS NO HARDWARE PROBLEM IDENTIFIED THAT COULD HAVE HAD AN IMPACT ON RESULT INTERPRETATION. TRUE AMPLIFICATION WAS OBSERVED FOR THE SARS-COV-2 TARGET AND NO PRODUCT PROBLEM WAS IDENTIFIED. ALTHOUGH ROOT CAUSE COULD NOT BE CONFIRMED, IT IS POSSIBLE THAT THE DISCREPANCY IS DUE TO SAMPLE HANDLING/MIX-UP AT THE CUSTOMER SITE AS MANY OTHER STRONG POSITIVE SAMPLES WERE OBSERVED IN THE CUSTOMERS DATASET. THE REAGENT LOT USED WAS TESTED INTERNALLY AND THE COMPLAINT ALLEGATION WAS NOT OBSERVED. NO PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION WAS IDENTIFIED.