CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS
Report
- Report Number
- 3004530258-2022-00088
- Event Type
- Malfunction
- Date Received
- September 12, 2022
- Date of Event
- August 15, 2022
- Report Date
- September 12, 2022
- Manufacturer
- CEPHEID
- Product Code
- QJR
- PMA / PMN Number
- EUA210505
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 501
Narratives
US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS. ON (B)(6) 2022, CUSTOMER REPORTED THAT A PATIENT SAMPLE TESTED AT UNKNOWN DATE AND TIME HAD ENCOUNTERED A SARS COV-2 POS/ FLU A POS/ FLU B POS/ RSV NEG RESULT ON XPRESS SARS COV-2/FLU/RSV PLUS ADF 1 LOT UNKNOWN. THE MEDICAL TEAM THOUGHT IT WAS ODD TO HAVE THAT COMBINATION IF RESULTS AND REQUESTED A TECHNICIAN TO RUN QC. QC WAS SUCCESSFULLY RUN, AND THEY RE-RAN THE ORIGINAL SAMPLE ON AN UNKNOWN DATE AND TIME ON XPRESS SARS COV-2/FLU/RSV PLUS ADF 1 LOT UNKNOWN, WHICH RESULTED IN SARS COV-2 NEG/ FLU A NEG/ FLU B NEG/ RSV NEG. THE SAME PATIENT SAMPLE WAS IN A DIFFERENT LAB AND RECEIVED NEGATIVE RESULTS. CUSTOMER UNABLE TO PROVIDE DATA OR ADDITIONAL INFORMATION REGARDING THE SAMPLE WITHIN THE ALLOTTED TIME. THIS IS A CASE WHEREBY A PATIENT SAMPLE WAS RESULTED WITH SARS-COV-2 AND FLU A&B POSITIVE/DETECTED WITH ALL TARGETS BEING NEGATIVE UPON REPEAT. WE DID NOT RECEIVE GXX/NXX FILES FOR BOTH RESULTS AND UNABLE TO CONCLUDE ON A PROBABLE ROOT CAUSE. POSSIBLE ROOT CAUSES ARE: CONTAMINATION OF THE TEST WITH OTHER TARGETS DURING PRE-ANALYTICAL PHASE. RANDOM CARTRIDGE ERROR CREATING NOISE - PARTICULATES, IMPROPER TUBE FILL, LEAKS. RANDOM INSTRUMENT ERROR CREATING A NOISE - MODULE OPTICS, ELECTRICAL SURGE. MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER TO OBTAIN MORE INFORMATION INCLUDING THE LOT NUMBER AND DISCUSS THE CASE HAVE BEEN UNANSWERED. SHOULD ADDITIONAL INFORMATION BE RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FALSE POSITIVE: 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 THE XPERT XPRESS COV-2/FLU/RSV PLUS EUA IFU; "POSITIVE RESULTS ARE INDICATIVE OF ACTIVE INFECTION, BUT DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER PATHOGENS NOT DETECTED BY THE TEST. CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS." NOTE FOR DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS COV-2/FLU/RSV PLUS TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS PATIENT RESULTS. ON (B)(6) 2022, CUSTOMER REPORTED THAT A PATIENT SAMPLE TESTED AT UNKNOWN DATE AND TIME HAD ENCOUNTERED A SARS COV-2 POS/ FLU A POS/ FLU B POS/ RSV NEG RESULT ON XPRESS SARS COV-2/FLU/RSV PLUS ADF 1 LOT UNKNOWN. THE MEDICAL TEAM THOUGHT IT WAS ODD TO HAVE THAT COMBINATION IF RESULTS AND REQUESTED A TECHNICIAN TO RUN QC. QC WAS SUCCESSFULLY RUN, AND THEY RE-RAN THE ORIGINAL SAMPLE ON AN UNKNOWN DATE AND TIME ON XPRESS SARS COV-2/FLU/RSV PLUS ADF 1 LOT UNKNOWN, WHICH RESULTED IN SARS COV-2 NEG/ FLU A NEG/ FLU B NEG/ RSV NEG. THE SAME PATIENT SAMPLE WAS IN A DIFFERENT LAB AND RECEIVED NEGATIVE RESULTS. CUSTOMER UNABLE TO PROVIDE DATA OR ADDITIONAL INFORMATION REGARDING THE SAMPLE WITHIN THE ALLOTTED TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2392389 | CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS | COVID-19 RT-PCR TEST | QJR | CEPHEID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |