CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV
Report
- Report Number
- 3004530258-2021-00395
- Event Type
- Malfunction
- Date Received
- September 22, 2021
- Date of Event
- August 25, 2021
- Report Date
- September 22, 2021
- Manufacturer
- CEPHEID
- Product Code
- QJR
- PMA / PMN Number
- EUA200453
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER HAD 12 PATIENT RESULTS THAT WERE QUESTIONED. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 1 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 1 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 1 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 2 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 2 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 2 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 3 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 3 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 3 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 4 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 4 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 4 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 5 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 5 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 5 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 6 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 6 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 6 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 7 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 7 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 7 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 8 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 8 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 8 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 9 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 9 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 9 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 10 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 10 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 10 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 11 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 11 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 11 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 12 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 12 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 12 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). THERE WAS NOT ENOUGH DATA TO DETERMINE ROOT CAUSE. ROOT CAUSE IS INCONCLUSIVE. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED PATIENT HARM. FALSE POSITIVE RESULTS FOR SARS-COV-2 COULD LEAD TO INCORRECT MANAGEMENT OF SYMPTOMATIC PATIENTS, INCLUDING UNNECESSARY ISOLATION OR QUARANTINE, MISALLOCATION OF RESOURCES, DELAYED DIAGNOSIS AND TREATMENT FOR OTHER INFECTIONS OR HEALTH CONDITIONS, OR UNNECESSARY ANTIVIRAL TREATMENT. CEPHEID'S PATIENT SAFETY BOARD CONSULT CONFIRMED WITH THE CUSTOMER THAT THERE WAS NO ASSOCIATED PATIENT HARM OR CHANGE TO PATIENT TREATMENT. RESULTS ARE FOR THE IDENTIFICATION OF SARS-COV-2 RNA. AS PER SECTION 3 OF XPERT XPRESS SARS-COV-2/FLU/RSV EUA IFU; POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. NOTE FOR SECTION DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS SARS-COV-2/FLU/RSV TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID..
US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV TESTED ON THE GENEXPERT INSTRUMENT. CUSTOMER HAD 12 PATIENT RESULTS THAT WERE QUESTIONED. CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 1 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 1 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 1 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 2 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 2 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 2 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 3 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 3 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 3 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 4 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 4 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 4 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 5 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 5 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 5 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 6 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 6 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 6 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 7 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 7 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 7 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 8 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 8 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 8 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 9 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 9 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 9 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 10 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 10 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 10 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 11 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 11 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 11 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). CUSTOMER COLLECTED SAMPLE 1 FROM PATIENT 12 ON (B)(6) 2021 WHICH WAS TESTED ON XPERT XPRESS SARS-COV-2/FLU/RSV AND RESULTED AS SARS-COV-2 POSITIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 2 FOR PATIENT 12 COLLECTED ON UNKNOWN DATE WHICH WAS TESTED ON AN UNKNOWN PLATFORM AT THE COUNTY HEALTH CLINIC AND RESULTED AS SARS-COV-2 NEGATIVE (UNKNOWN IF REPORTED TO THE PHYSICIAN). SAMPLE 1 RETEST 1 FOR PATIENT 12 OCCURRED ON (B)(6) 2021 AND TESTED WITH EITHER XPERT XPRESS SARS-COV-2 OR XPERT XPRESS SARS-COV-2/FLU/RSV WITH AN UNKNOWN RESULT (UNKNOWN IF REPORTED TO THE PHYSICIAN). REVIEW OF DATA PROVIDED BY THE CUSTOMER SHOWED NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1408761 | CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV | COVID-19 RT-PCR TEST | QJR | CEPHEID | 1000249252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |