Description of Event or Problem · 0
US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV. CUSTOMER COLLECTED SAMPLE FROM PATIENT 1 ON (B)(6) 2021, WHICH WAS TESTED ON BIOFIRE RP2.1 AND RESULTED AS SARS POSITIVE AND RSV POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE-1 RETEST-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV, RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE-1 RETEST-2 OCCURRED ON (B)(6) 2021 AND TESTED ON ALINITY RESULTED IN SARS POSITIVE (REPORTED TO THE PHYSICIAN). PATIENT 2 SAMPLE COLLECTED ON (B)(6) 2021, TESTED ON BIOFIRE RP2.1, RESULTED IN SARS POSITIVE, RHINO POSITIVE, CORONA OC43 POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE-1 RETEST-1 TAKEN (B)(6) 2021, TESTED ON BIOFIRE RP2.1 RESULTED IN SARS POSITIVE, RHINO POSITIVE, CORONA OC43 POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE-1 RETEST-2 TAKEN (B)(6) 2021 TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (REPORTED TO THE PHYSICIAN). SAMPLE-1 RETEST-3 TAKEN (B)(6) 2021 TESTED ON ALINITY, RESULTED SARS POSITIVE (REPORTED TO THE PHYSICIAN). REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO KNOWN HARM TO PATIENT.