CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV
Report
- Report Number
- 3004530258-2021-00424
- Event Type
- Malfunction
- Date Received
- November 16, 2021
- Date of Event
- October 28, 2021
- Report Date
- November 15, 2021
- Manufacturer
- CEPHEID
- Product Code
- QJR
- PMA / PMN Number
- EUA200453
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV. 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 POSITIVE, FLU B NEGATIVE, RSV POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV, WHICH RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (REPORTED TO THE PHYSICIAN). THE ROOT CAUSE WAS DETERMINED TO BE CONTAMINATION AND/OR CARRYOVER. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED 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 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. DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS SARS-COV-2/FLU/RSV 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. 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 POSITIVE, FLU B NEGATIVE, RSV POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV, WHICH RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (REPORTED TO THE PHYSICIAN). THE ROOT CAUSE WAS DETERMINED TO BE CONTAMINATION AND/OR CARRYOVER. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AND THERE WAS NO REPORTED 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 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. DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS SARS-COV-2/FLU/RSV 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. 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 POSITIVE, FLU B NEGATIVE, RSV POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV, WHICH RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (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.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS FOR XPERT XPRESS SARS-COV-2/FLU/RSV. 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 POSITIVE, FLU B NEGATIVE, RSV POSITIVE (REPORTED TO THE PHYSICIAN). SAMPLE 1 REPEAT-1 OCCURRED ON (B)(6) 2021 AND TESTED ON XPERT XPRESS SARS COV-2/FLU/RSV, WHICH RESULTED IN SARS-COV-2 NEGATIVE, FLU A NEGATIVE, FLU B NEGATIVE, RSV NEGATIVE (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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1717345 | CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV | COVID-19 RT-PCR TEST | QJR | CEPHEID | 1000316077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |