CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS
Report
- Report Number
- 3004530258-2023-00021
- Event Type
- Malfunction
- Date Received
- December 27, 2023
- Date of Event
- November 29, 2023
- Report Date
- January 4, 2024
- Manufacturer
- CEPHEID
- Product Code
- QJR
- PMA / PMN Number
- EUA210505
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 501
Narratives
US CUSTOMER CONTACTED CEPHEID TO DISCUSS A DISCREPANT RESULT USING XPERT XPRESS COV-2/FLU/RSV PLUS. CUSTOMER INITIALLY RAN CONTROLS (B)(6) 2023, AS THEY NOTICED AN UPTICK IN FLU BS. INITIAL QC CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B POS/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS. CUSTOMER THEN THE DECONTAMINATED THE INSTRUMENT AND RE-RAN NEG QC, WHICH CAME UP SARS COV-2 NEG/FLU A POS/ FLU B POS/ RSV NEG. CUSTOMER THEN DECONTAMINATED THE INSTRUMENT AGAIN. CUSTOMER THEN RAN 2 BLANK NEGATIVE QCS WITH SALINE. BOTH SALINE BLANKS CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B POS/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS ON (B)(6) 2023. CARTS ARE STORED IN THE SAME ROOM AS INSTRUMENT. SWABS ARE STORED IN PATIENT ROOM. NO PATIENT TESTING HAD BEEN DONE SINCE (B)(6) 2023. SALINE IS FROM STOCK SOL'N. CUSTOMER OPENED A BRAND NEW SALINE SOL'N AND NEW KIT BOX AND RETESTED 2 MORE CARTS, AND BOTH CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B NEG/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS ON (B)(6) 2023. CUSTOMER DECONTAMINATED THE INSTRUMENT AGAIN. ON (B)(6) 2023, NEGATIVE QC PASSED W/NO TRACE AMPLIFICATION, BUT ALL 4 PATIENT SAMPLES FROM (B)(6) 2023 CAME BACK FLU B POS. ALL SAMPLES ARE COLLECTED IN SALINE AND WERE TESTED N XPERT XPRESS COV-2/FLU/RSV PLUS AND STORED AT ROOM TEMP AND RIGHT AFTER COLLECTION. ALL PATIENTS WERE SYMPTOMATIC, AND ALL RESULTS WERE REPORTED TO THE PHYSICIAN. ALL TESTING WAS PERFORMED ON (B)(6) 2023. PATIENT (B)(6): FLU B CT 26.3 EPF 805. SARS : CT 0 EPF 2. FLUA 1: CT 0 EPF -6. FLU A 2: CT 0 EPF1. RSV: CT 0 EPF 1. SAME ORIGINAL SAMPLES SENT TO HEALTH TRACK RX REFERENCE LAB, WHICH ALSO USES PCR. PATIENT (B)(6)CAME BACK WITH MORAXELLA CATARRHALIS. PATIENT (B)(6): SARS CT 0 EPF -4. FLU A1: CT 0 EPF -6. FLU A2 : CT 0 EPF-2. FLU B: CT 23.1 EPF 863. RSV: CT 0 EPF -1. PATIENT (B)(6): SARS CT 0, EPF 1. A1: CT 0, EPF -3. A2: CT 0, EPF 1. FLU B: CT 27.2 EPF 679. RSV: CT 0, EPF -2. PATIENT (B)(6): FLU A1: CT 0.0, EPF -5. FLU A2 : CT 0.0, EPF1. FLU B: CT 26.2 EPF 661. RSV: CT 0, EPF 6. SAME ORIGINAL SAMPLES SENT TO HEALTH TRACK RX REFERENCE LAB, WHICH ALSO USES PCR. PATIENT (B)(6) CAME BACK WITH RHINOVIRUS. THE INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION REGARDING LIKELY ROOT CAUSE WILL BE PROVIDED IN A FOLLOW UP REPORT ONCE THE INVESTIGATION HAS BEEN COMPLETED.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS A DISCREPANT RESULT USING XPERT XPRESS COV-2/FLU/RSV PLUS. CUSTOMER INITIALLY RAN CONTROLS (B)(6) 2023, AS THEY NOTICED AN UPTICK IN FLU BS. INITIAL QC CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B POS/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS. CUSTOMER THEN THE DECONTAMINATED THE INSTRUMENT AND RE-RAN NEG QC, WHICH CAME UP SARS COV-2 NEG/FLU A POS/ FLU B POS/ RSV NEG. CUSTOMER THEN DECONTAMINATED THE INSTRUMENT AGAIN. CUSTOMER THEN RAN 2 BLANK NEGATIVE QCS WITH SALINE. BOTH SALINE BLANKS CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B POS/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS ON (B)(6) 2023. CARTS ARE STORED IN THE SAME ROOM AS INSTRUMENT. SWABS ARE STORED IN PATIENT ROOM. NO PATIENT TESTING HAD BEEN DONE SINCE (B)(6) 2023. SALINE IS FROM STOCK SOL'N. CUSTOMER OPENED A BRAND NEW SALINE SOL'N AND NEW KIT BOX AND RETESTED 2 MORE CARTS, AND BOTH CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B NEG/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS ON (B)(6) 2023. CUSTOMER DECONTAMINATED THE INSTRUMENT AGAIN. ON (B)(6) 2023, NEGATIVE QC PASSED W/NO TRACE AMPLIFICATION, BUT ALL 4 PATIENT SAMPLES FROM 30-NOV-2023 CAME BACK FLU B POS. ALL SAMPLES ARE COLLECTED IN SALINE AND WERE TESTED N XPERT XPRESS COV-2/FLU/RSV PLUS AND STORED AT ROOM TEMP AND RIGHT AFTER COLLECTION. ALL PATIENTS WERE SYMPTOMATIC, AND ALL RESULTS WERE REPORTED TO THE PHYSICIAN. ALL TESTING WAS PERFORMED ON (B)(6) 2023. PATIENT 1: FLU B CT 26.3 EPF 805. SARS : CT 0 EPF 2. FLUA 1: CT 0 EPF -6. FLU A 2: CT 0 EPF1. RSV: CT 0 EPF 1. SAME ORIGINAL SAMPLES SENT TO HEALTH TRACK RX REFERENCE LAB, WHICH ALSO USES PCR. PATIENT 1 CAME BACK WITH MORAXELLA CATARRHALIS. PATIENT 2: SARS CT 0 EPF -4. FLU A1: CT 0 EPF -6. FLU A2 : CT 0 EPF-2. FLU B: CT 23.1 EPF 863. RSV: CT 0 EPF -1. PATIENT 3: SARS CT 0, EPF 1. A1: CT 0, EPF -3. A2: CT 0, EPF 1. FLU B: CT 27.2 EPF 679. RSV: CT 0, EPF -2. PATIENT 4: FLU A1: CT 0.0, EPF -5. FLU A2 : CT 0.0, EPF1. FLU B: CT 26.2 EPF 661. RSV: CT 0, EPF 6. SAME ORIGINAL SAMPLES SENT TO HEALTH TRACK RX REFERENCE LAB, WHICH ALSO USES PCR. PATIENT 4 CAME BACK WITH RHINOVIRUS. THIS IS A CASE WHEREBY THE CUSTOMER PERSISTENTLY RECEIVED A POSITIVE FLU B ACROSS MULTIPLE PATIENTS WITH RETESTS WITH A REFERENCE LABORATORY RESULTING IN OTHER ETIOLOGIC AGENTS OR NEGATIVE. REVIEW OF THE RESULTS SHOW CT'S IN THE MID-20'S WITH HIGH EPFS THAT APPEAR FROM PATIENTS WITH ACTIVE DISEASE, LIKELY FROM CONTAMINATION OF CONTROLS, BUT WITHOUT FURTHER INFORMATION, CANNOT RULE OUT OTHER CONSIDERATIONS FROM SAMPLING, TRANSPORT MEDIA, OR THE OPERATOR. THE LIKELY ROOT CAUSE IN THIS CASE IS CONTAMINATION AND/OR CARRYOVER. NO PRODUCT MALFUNCTION NOR PATIENT HARM INDICATED. AFTER FURTHER INVESTIGATION, THE CASE WAS DEEMED NOT REPORTABLE. SECTION H6 INVESTIGATION FINDINGS AND INVESTIGATIONS CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT THE OUTCOME. 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 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.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS A DISCREPANT RESULT USING XPERT XPRESS COV-2/FLU/RSV PLUS. CUSTOMER INITIALLY RAN CONTROLS (B)(6) 2023, AS THEY NOTICED AN UPTICK IN FLU BS. INITIAL QC CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B POS/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS. CUSTOMER THEN THE DECONTAMINATED THE INSTRUMENT AND RE-RAN NEG QC, WHICH CAME UP SARS COV-2 NEG/FLU A POS/ FLU B POS/ RSV NEG. CUSTOMER THEN DECONTAMINATED THE INSTRUMENT AGAIN. CUSTOMER THEN RAN 2 BLANK NEGATIVE QCS WITH SALINE. BOTH SALINE BLANKS CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B POS/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS ON (B)(6) 2023. CARTS ARE STORED IN THE SAME ROOM AS INSTRUMENT. SWABS ARE STORED IN PATIENT ROOM. NO PATIENT TESTING HAD BEEN DONE SINCE (B)(6) 2023. SALINE IS FROM STOCK SOL'N. CUSTOMER OPENED A BRAND NEW SALINE SOL'N AND NEW KIT BOX AND RETESTED 2 MORE CARTS, AND BOTH CAME UP SARS COV-2 NEG/FLU A NEG/ FLU B NEG/ RSV NEG ON XPERT XPRESS COV-2/FLU/RSV PLUS ON (B)(6) 2023. CUSTOMER DECONTAMINATED THE INSTRUMENT AGAIN. ON (B)(6) 2023, NEGATIVE QC PASSED W/NO TRACE AMPLIFICATION, BUT ALL 4 PATIENT SAMPLES FROM (B)(6) 2023 CAME BACK FLU B POS. ALL SAMPLES ARE COLLECTED IN SALINE AND WERE TESTED N XPERT XPRESS COV-2/FLU/RSV PLUS AND STORED AT ROOM TEMP AND RIGHT AFTER COLLECTION. ALL PATIENTS WERE SYMPTOMATIC, AND ALL RESULTS WERE REPORTED TO THE PHYSICIAN. ALL TESTING WAS PERFORMED ON (B)(6) 2023. PATIENT (B)(6): FLU B CT 26.3 EPF 805. SARS : CT 0 EPF 2. FLUA 1: CT 0 EPF -6. FLU A 2: CT 0 EPF1. RSV: CT 0 EPF 1. SAME ORIGINAL SAMPLES SENT TO HEALTH TRACK RX REFERENCE LAB, WHICH ALSO USES PCR. PATIENT 1 CAME BACK WITH MORAXELLA CATARRHALIS. PATIENT (B)(6): SARS CT 0 EPF -4. FLU A1: CT 0 EPF -6. FLU A2 : CT 0 EPF-2. FLU B: CT 23.1 EPF 863. RSV: CT 0 EPF -1. PATIENT (B)(6): SARS CT 0, EPF 1. A1: CT 0, EPF -3. A2: CT 0, EPF 1. FLU B: CT 27.2 EPF 679. RSV: CT 0, EPF -2. PATIENT (B)(6): FLU A1: CT 0.0, EPF -5. FLU A2 : CT 0.0, EPF1. FLU B: CT 26.2 EPF 661. RSV: CT 0, EPF 6. SAME ORIGINAL SAMPLES SENT TO HEALTH TRACK RX REFERENCE LAB, WHICH ALSO USES PCR. PATIENT (B)(6) CAME BACK WITH RHINOVIRUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1402149 | CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS | COVID-19 RT-PCR TEST | QJR | CEPHEID | 1001221524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |