CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS
Report
- Report Number
- 3004530258-2024-00014
- Event Type
- Injury
- Date Received
- September 24, 2024
- Date of Event
- August 9, 2024
- Report Date
- January 9, 2025
- Manufacturer
- CEPHEID
- Product Code
- QJR
- PMA / PMN Number
- EUA210505
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 501
Narratives
AUSTRALIAN CUSTOMER CONTACTED CEPHEID ON 03-SEP-2024 TO REPORT A QUESTIONABLE NEGATIVE RESULT WITH THE XPERT XPRESS COV-2/FLU/RSV PLUS TEST. ON (B)(6) 2024, A COMBINED NOSE AND THROAT SWAB (OFF-LABEL) WAS COLLECTED INTO NOBLE BIO UTM THEN TRANSPORTED AT ROOM TEMPERATURE TO THE LABORATORY AT THE (B)(6) HOSPITAL, (B)(6). THE SAMPLE WAS RECEIVED BY THE LABORATORY ON 09-AUG-2024 AND STORED AT ROOM TEMPERATURE UNTIL TESTING. IT IS NOTED THAT THE NOBLE BIOSCIENCES COLLECTION DEVICE CONTAINS 2.0 ML OF UTM, CUSTOMER WAS MADE AWARE 2ML VTM IS OFF LABEL. AT 12:31 PM AEST ON (B)(6) 2024, THE CUSTOMER TESTED THE COMBINED NOSE AND THROAT SWAB SAMPLE (OFF-LABEL) WITH XPERT XPRESS COV-2/FLU/RSV PLUS TEST. THE SPECIMEN WAS NOT PROCESSED AND TESTED ACCORDING TO THE PI DUE TO 2ML UTM. THE SAMPLE WAS THEN STORED IN THE LABORATORY COOL ROOM AT 4C. THE RESULT FROM THE XPERT XPRESS COV-2/FLU/RSV PLUS TEST WAS ALL TARGETS NEGATIVE, WITH SARS-COV-2 CT = 0.0 AND EPF = 36. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS THEN TRANSPORTED AT 4C TO THE CENTRAL LABORATORY AT (B)(6) FOR ADDITIONAL RESPIRATORY TESTING. AT 1:06 PM AEST ON (B)(6) 2024, THE SAMPLE WAS TESTED ON THE SEEGENE RV-MASTER ASSAY, WHICH RESULTED AS SARS-COV-2 POSITIVE WITH SARS-COV-2 CT = 33. THE SAMPLE WAS THEN STORED IN THE LABORATORY COOL ROOM AT 4C. AT 5:20 PM AEST ON (B)(6) 2024, THE SAMPLE WAS REPEATED WITH XPERT XPRESS COV-2/FLU/RSV PLUS TEST. THE SPECIMEN WAS NOT PROCESSED AND TESTED ACCORDING TO THE PI DUE TO THE 2ML UTM. THE RESULT FROM THE REPEAT XPERT XPRESS COV-2/FLU/RSV PLUS TEST WAS SARS-COV-2 POSITIVE, WITH SARS-COV-2 CT = 34.8 AND EPF = 328. BASED ON THE SEEGENE AND REPEAT GENEXPERT RESULTS, AN AMENDED REPORT WAS ISSUED. WHILE NO PATIENT HARM WAS REPORTED, THE REQUESTING DOCTOR AND HOSPITAL PATIENT WERE UNHAPPY DUE TO THE FALSE NEGATIVE INITIAL TEST RESULT. THE CLINICAL IMPACT IS UNKNOWN; HOWEVER, THE PATIENT IS 86 YEARS OF AGE AND WOULD HAVE QUALIFIED FOR ANTIVIRAL THERAPY IF THE RESULT HAD BEEN CORRECT. ALSO, AS THIS WAS IN A HOSPITAL, THE FALSE NEGATIVE RESULT FOR SARS-COV-2 HAS INFECTION CONTROL IMPLICATIONS FOR OTHER PATIENTS AND HOSPITAL STAFF. THE PATIENT WAS SYMPTOMATIC, AND THE PATIENT'S COVID-19 IMMUNIZATION STATUS IS UNKNOWN. THERE IS NO SAMPLE LEFTOVER FOR FURTHER TESTING. THIS CASE RELATES TO AN 86-YEAR-OLD HOSPITAL INPATIENT WHO DEVELOPED RESPIRATORY SYMPTOMS. SAMPLE 1 WAS COLLECTED ON 09-AUG-2024 USING A SINGLE SWAB FROM THE NP AND THROAT REGION AND STORED IN 2 ML OF NOBLE BIOSCIENCES VTM. BOTH METHODS ARE OFF LABEL AND HAVE BEEN VALIDATED ACROSS MULTIPLE SNP LAB SITES. XPERT XPRESS COV-2/FLU/RSV PLUS TEST 1 WAS RUN ON (B)(6) 2024 AND GENERATED A NEGATIVE RESULT - FOR COVID, FLU AB AND RSV. THIS RESULT WAS REPORTED TO THE REQUESTING CLINICIAN. THE ANALYTICAL SPC ANOMALY (SPC CT = 37.6, EPF =36) IN XPERT XPRESS COV-2/FLU/RSV PLUS TEST 1 WAS NOTICED BY THE LAB. ON (B)(6) 2024 THE LAB RETESTED THE ORIGINAL SAMPLE USING THE SEEGENE RV MASTER ASSAY - RESULT WAS COVID POSITIVE CT 33.0. THIS RESULT WAS REPORTED TO THE CLINICIAN. A SECOND XPERT XPRESS COV-2/FLU/RSV PLUS TEST WAS RUN ON A DIFFERENT LOT ON (B)(6) 2024 BASED ON THE POSITIVE SEEGENE RESULT AND WAS COVID POSITIVE CT 34.8. NO PATIENT HARM WAS REPORTED. HOWEVER, HOSPITAL STAFF EXPRESSED CONCERNS REGARDING A 10-HOUR DELAY IN STARTING ANTIVIRALS FOR THIS PATIENT AND NOT BEING ABLE TO IMPLEMENT INFECTION CONTROL MEASURES SOONER. INTERNAL REVIEW OF TEST FILES AT CEPHEID SHOWED NO ABNORMALITIES IN EITHER TEST. THE PCR AMPLIFICATION CURVES WERE SIGMOIDAL AND CONSISTENT WITH SUCCESSFUL CYCLES OF PCR.. THERE ARE NO KNOWN LOT PROBLEMS OR SYSTEMIC ISSUES WITH THE LOT USED FOR THE FIRST TEST. THERE MAY HAVE BEEN THE A PRESENCE OF SAMPLE INHIBITORS; HOWEVER, ANY INHIBITORS WOULD HAVE BEEN FROM THE SAMPLE ITSELF OR INTRODUCED AT THE TIME OF SAMPLE COLLECTION AND NOT DURING SAMPLE PROCESSING DURING TRANSFER TO TEST CARTRIDGE AS THE CUSTOMER LAB STAFF IS VERY EXPERIENCED. THIS COULD BE AN INDIVIDUAL CARTRIDGE FAILURE EVENT, HOWEVER SINCE THE TEST WAS PERFORMED OFF-LABEL, CEPHEID HAS NOT PERFORMED ANY STUDIES TO RULE OUT OFF-LABEL SAMPLE TYPE AND/OR OFF-LABEL COLLECTION DEVICE AS BEING THE ROOT CAUSE AGAIN, THERE WAS NO HARM TO THE PATIENT, HOWEVER CEPHEID IS CONSIDERING THIS TO BE A NEAR MISS ADVERSE EVENT (AUSTRALIAN THERAPEUTICS GOODS ASSOCIATION (TGA) GUIDELINES) DUE TO THE PATIENT BEING PART OF THE POPULATION AT GREATEST RISK DUE TO AGE. CEPHEID IS REPORTING THIS TO FDA TO ALIGN WITH AUSTRALIAN REQUIREMENTS FOR TGA. FALSE NEGATIVE: AS PER SECTION 3 OF THE XPERT XPRESS SARS-COV-2/FLU/RSV PLUS IFU; "NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2, INFLUENZA A VIRUS, INFLUENZA B VIRUS AND/OR RSV INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR OTHER PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND/OR EPIDEMIOLOGICAL INFORMATION. " NOTE FOR SECTION H3 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.
INCORRECT LOT NUMBER WAS PROVIDED IN IN THE INITIAL REPORT IN SECTION B5 AND H11. LOT 19926 WAS PROVIDED AND IS INCORRECT. THE CORRECT LOT IS 19226 THE OUTCOME OF THE INVESTIGATION REMAINS THE SAME.
AUSTRALIAN CUSTOMER CONTACTED CEPHEID ON 03-SEP-2024 TO REPORT A QUESTIONABLE NEGATIVE RESULT WITH THE XPERT XPRESS COV-2/FLU/RSV PLUS TEST. ON (B)(6) 2024, A COMBINED NOSE AND THROAT SWAB (OFF-LABEL) WAS COLLECTED INTO NOBLE BIO UTM THEN TRANSPORTED AT ROOM TEMPERATURE TO THE LABORATORY AT THE (B)(6) HOSPITAL, (B)(6). THE SAMPLE WAS RECEIVED BY THE LABORATORY ON 09-AUG-2024 AND STORED AT ROOM TEMPERATURE UNTIL TESTING. IT IS NOTED THAT THE NOBLE BIOSCIENCES COLLECTION DEVICE CONTAINS 2.0 ML OF UTM, CUSTOMER WAS MADE AWARE 2ML VTM IS OFF LABEL. AT 12:31 PM AEST ON (B)(6) 2024, THE CUSTOMER TESTED THE COMBINED NOSE AND THROAT SWAB SAMPLE (OFF-LABEL) WITH XPERT XPRESS COV-2/FLU/RSV PLUS TEST. THE SPECIMEN WAS NOT PROCESSED AND TESTED ACCORDING TO THE PI DUE TO 2ML UTM. THE SAMPLE WAS THEN STORED IN THE LABORATORY COOL ROOM AT 4C. THE RESULT FROM THE XPERT XPRESS COV-2/FLU/RSV PLUS TEST WAS ALL TARGETS NEGATIVE, WITH SARS-COV-2 CT = 0.0 AND EPF = 36. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS THEN TRANSPORTED AT 4C TO THE CENTRAL LABORATORY AT (B)(6) FOR ADDITIONAL RESPIRATORY TESTING. AT 1:06 PM AEST ON (B)(6) 2024, THE SAMPLE WAS TESTED ON THE SEEGENE RV-MASTER ASSAY, WHICH RESULTED AS SARS-COV-2 POSITIVE WITH SARS-COV-2 CT = 33. THE SAMPLE WAS THEN STORED IN THE LABORATORY COOL ROOM AT 4C. AT 5:20 PM AEST ON (B)(6) 2024, THE SAMPLE WAS REPEATED WITH XPERT XPRESS COV-2/FLU/RSV PLUS TEST. THE SPECIMEN WAS NOT PROCESSED AND TESTED ACCORDING TO THE PI DUE TO THE 2ML UTM. THE RESULT FROM THE REPEAT XPERT XPRESS COV-2/FLU/RSV PLUS TEST WAS SARS-COV-2 POSITIVE, WITH SARS-COV-2 CT = 34.8 AND EPF = 328. BASED ON THE SEEGENE AND REPEAT GENEXPERT RESULTS, AN AMENDED REPORT WAS ISSUED. WHILE NO PATIENT HARM WAS REPORTED, THE REQUESTING DOCTOR AND HOSPITAL PATIENT WERE UNHAPPY DUE TO THE FALSE NEGATIVE INITIAL TEST RESULT. THE CLINICAL IMPACT IS UNKNOWN; HOWEVER, THE PATIENT IS 86 YEARS OF AGE AND WOULD HAVE QUALIFIED FOR ANTIVIRAL THERAPY IF THE RESULT HAD BEEN CORRECT. ALSO, AS THIS WAS IN A HOSPITAL, THE FALSE NEGATIVE RESULT FOR SARS-COV-2 HAS INFECTION CONTROL IMPLICATIONS FOR OTHER PATIENTS AND HOSPITAL STAFF. THE PATIENT WAS SYMPTOMATIC, AND THE PATIENT'S COVID-19 IMMUNIZATION STATUS IS UNKNOWN. THERE IS NO SAMPLE LEFTOVER FOR FURTHER TESTING. CT AND END POINT FLUORESCENCE VALUES ARE LISTED BELOW: INITIAL TESTING: XPERT XPRESS SARS-COV-2_FLU_RSV PLUS, LOT 19926, ADF 2, GENEXPERT SN (B)(6) SARS-COV-2: CT-0.0; EPF: 36 FLU A1: CT-0.0; EPF: 1 FLU A2: CT-0.0; EPF: 0 FLU B: CT-0.0; EPF: -1 RSV: CT-0.0; EPF: 1 SPC CT-37.6; EPF: 80 REPEAT TESTING: XPERT XPRESS SARS-COV-2_FLU_RSV PLUS, LOT 19219, ADF 1, GENEXPERT SN (B)(6) SARS-COV-2: CT-34.8; EPF: 328 FLU A1: CT-0.0; EPF: 0 FLU A2: CT-0.0; EPF: 0 FLU B: CT-0.0; EPF: 0 RSV: CT-0.0; EPF: -2 SPC CT-28.8; EPF: 175.
LOT 19926 WAS PROVIDED AND IS INCORRECT. THE CORRECT LOT IS 19226
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2239172 | CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS | COVID-19 RT-PCR TEST | QJR | CEPHEID | 1001424099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Unknown | Other |