FILMARRAY® PNEUMONIA PANEL PLUS
Report
- Report Number
- 3002773840-2024-00378
- Event Type
- Death
- Date Received
- August 29, 2024
- Report Date
- September 20, 2024
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- QDS
- UDI-DI
- 00815381020314
- PMA / PMN Number
- K181324
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: ACCORDING TO THE STUDY, THE PATIENT HAD ESCHERICHIA COLI EXTENDED SPECTRUM BETA-LACTAMASE (ESBL) RELATED VENTILATOR-ASSOCIATED PNEUMONIA (VAP) 15 DAYS PRIOR TO THIS EPISODE. AT THE TIME OF THE FILMARRAY PNEUMONIA PANEL PLUS SAMPLE COLLECTION, THE PATIENT WAS BEING TREATED WITH PIPERACILLIN AND TAZOBACTAM. THE FILMARRAY PNEUMONIA PANEL PLUS WAS POSITIVE FOR PSEUDOMONAS AERUGINOSA AND CTX-M AFTER TESTING AN ENDOTRACHEAL ASPIRATE SAMPLE THAT HAD BEEN PRE-TREATED WITH A MUCOLYTIC SOLUTION. PLEASE NOTE THAT TREATING A SAMPLE WITH A MUCOLYTIC SOLUTION IS CONSIDERED AN OFF-LABEL USE OF THE FILMARRAY PNEUMONIA PANEL PLUS. CULTURE IDENTIFICATION WAS PERFORMED USING BRUKER DALTONICS - MICROFLEX LT MALDI-TOF MS, AND ANTIMICROBIAL SUSCEPTIBILITY TESTING WAS DETERMINED BY DISK DIFFUSION ON MUELLER-HINTON MEDIA. ONLY P. AERUGINOSA WAS RECOVERED FROM CULTURE. DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT RECEIVED MEROPENEM PLUS AMIKACIN AS EMPIRICAL ANTIBIOTIC THERAPY. THE OUTCOME OF THE PATIENT WAS UNFAVORABLE, AND THEY PASSED AWAY WITHIN 48 HOURS DUE TO MULTIORGAN FAILURE. BIOFIRE REQUESTED FURTHER INFORMATION FROM THE AUTHOR TO CLARIFY WHETHER THE FILMARRAY PNEUMONIA PANEL PLUS RESULT CONTRIBUTED TO THE PATIENT'S DEATH, HOWEVER, DESPITE MULTIPLE ATTEMPTS, BIOFIRE WAS UNABLE TO RECEIVE FURTHER INFORMATION FROM THE AUTHOR. THE BIOFIRE MEDICAL AFFAIRS TEAM REVIEWED THIS CASE AND DETERMINED THAT IT IS HIGHLY UNLIKELY THAT THE FILMARRAY PNEUMONIA PANEL PLUS RESULT CONTRIBUTED TO THE PATIENT'S DEATH. ALTHOUGH, IT IS WELL KNOWN THAT SEVERE VAP WITH SEPSIS CAN OFTEN RESULT IN MULTI-ORGAN FAILURE AND DEATH, MEROPENEM/AMIKACIN IS NOT KNOWN TO CAUSE RAPID MULTI-ORGAN FAILURE AND DEATH WITHIN 48 HOURS. IT IS HIGHLY UNLIKELY THAT A BRIEF PERIOD OF ANTIBIOTIC ESCALATION, IN THIS SITUATION, RESULTED IN THE POOR OUTCOME. NO POUCH LOT INFORMATION OR RUN FILES WERE PROVIDED, THEREFORE SPECIFIC QC RECORDS WERE UNABLE TO BE REVIEWED. HOWEVER, ALL REAGENT PRODUCTS MANUFACTURED BY BIOFIRE UNDERGO QC AND MEET CRITERIA PRIOR TO BEING RELEASED. REFERENCE: BAY, PIERRE, ET AL. "PERFORMANCE AND IMPACT OF RAPID MULTIPLEX PCR ON DIAGNOSIS AND TREATMENT OF VENTILATED HOSPITAL-ACQUIRED PNEUMONIA IN PATIENTS WITH EXTENDED-SPECTRUM BETA-LACTAMASE-PRODUCING ENTEROBACTERIAL RECTAL CARRIAGE." ANNALS OF INTENSIVE CARE, VOL. 14, NO. 1, 29 JULY 2024, HTTPS://DOI.ORG/10.1186/S13613-024-01348-5. CONCLUSION: THE INVESTIGATION DETERMINED THAT THE STUDY USED A PRETREATED SAMPLE, AN OFF-LABEL SAMPLE TYPE, WHICH DEVIATES FROM THE INTENDED USE OF THE FILMARRAY PNEUMONIA PANEL PLUS. THE FILMARRAY PNEUMONIA PANEL PLUS IS A MULTIPLEXED NUCLEIC ACID TEST INTENDED FOR THE SIMULTANEOUS DETECTION AND IDENTIFICATION OF MULTIPLE RESPIRATORY VIRAL AND BACTERIAL NUCLEIC ACIDS, AS WELL AS SELECT ANTIMICROBIAL RESISTANCE GENES, IN SPUTUM-LIKE SPECIMENS (INDUCED OR EXPECTORATED SPUTUM, OR ENDOTRACHEAL ASPIRATES) OR BRONCHOALVEOLAR LAVAGE (BAL)-LIKE SPECIMENS (BAL OR MINI-BAL) OBTAINED FROM INDIVIDUALS SUSPECTED OF LOWER RESPIRATORY TRACT INFECTION. THE PUBLICATION STATED THAT THE PATIENT SAMPLE IN THE STUDY WAS PRETREATED WITH 200 UL OF THE MUCOLYTIC SL-DILUTED SOLUTION (COPAN). ACCORDING TO THE "SAMPLE REQUIREMENTS" SECTION OF THE FILMARRAY PNEUMONIA PANEL PLUS INSTRUCTIONS FOR USE (WWW.ONLINE-IFU.COM/ITI0038), BAL-LIKE OR SPUTUM-LIKE SPECIMENS SHOULD NOT BE CENTRIFUGED, PRE-PROCESSED, TREATED WITH ANY MUCOLYTIC OR DECONTAMINATING AGENTS (E.G., MYCOPREP, SPUTASOL, SNAP N' DIGEST, DTT, SODIUM HYDROXIDE, OXALIC ACID, TRYPSIN, ETC.), OR PLACED INTO TRANSPORT MEDIA BEFORE TESTING. ACCORDING TO THE "LIMITATION" SECTION OF THE FILMARRAY PNEUMONIA PANEL PLUS IFU, THE FILMARRAY PNEUMONIA PANEL PLUS HAS NOT BEEN VALIDATED FOR TESTING OF SPECIMENS OTHER THAN UNPROCESSED SPUTUM-LIKE AND BAL-LIKE SPECIMENS. ACCORDING TO THE STUDY, THE PATIENT WAS ON PIPERACILLIN AND TAZOBACTAM PRIOR TO TESTING ON THE FILMARRAY PNEUMONIA PANEL PLUS. IT SHOULD BE NOTED THAT THE EFFECT OF ANTIBIOTIC TREATMENT ON TEST PERFORMANCE INCLUDING SEMI-QUANTITATIVE BIN RESULTS HAS NOT BEEN SPECIFICALLY EVALUATED FOR THE FILMARRAY PNEUMONIA PANEL PLUS.
INVESTIGATION: DISCORDANT CTX-M RESULTS BETWEEN THE FILMARRAY PNEUMONIA PANEL PLUS AND CONVENTIONAL CULTURE WERE MENTIONED IN A PUBLICATION BY BAY ET AL. TITLED "PERFORMANCE AND IMPACT OF RAPID MULTIPLEX PCR ON DIAGNOSIS AND TREATMENT OF VENTILATED HOSPITAL-ACQUIRED PNEUMONIA IN PATIENTS WITH EXTENDED-SPECTRUM BETA-LACTAMASE-PRODUCING ENTEROBACTERALES RECTAL CARRIAGE." A PATIENT WITH A DISCORDANT CTX-M RESULT RECEIVED MEROPENEM PLUS AMIKACIN AS EMPIRICAL ANTIBIOTIC THERAPY AFTER THE FILMARRAY PNEUMONIA PANEL PLUS RESULT. THE OUTCOME OF THE PATIENT WAS NOTED AS UNFAVORABLE, AND THEY PASSED AWAY WITHIN 48 HOURS DUE TO MULTIORGAN FAILURE. IT IS UNKNOWN IF THE FILMARRAY PNEUMONIA PANEL PLUS RESULT CONTRIBUTED TO THE PATIENT'S DEATH. PLEASE NOTE THAT THE PATIENT'S ENDOTRACHEAL SAMPLE THAT WAS TESTED ON THE FILMARRAY PNEUMONIA PANEL PLUS HAD BEEN PRE-TREATED WITH A MUCOLYTIC SOLUTION. TREATING A FILMARRAY PNEUMONIA PANEL PLUS SAMPLE WITH A MUCOLYTIC SOLUTION IS CONSIDERED AN OFF-LABEL USE OF THE PANEL. BIOFIRE'S INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FSCA HAS BEEN DEEMED NECESSARY AT THIS TIME. REFERENCE: BAY, PIERRE, ET AL. "PERFORMANCE AND IMPACT OF RAPID MULTIPLEX PCR ON DIAGNOSIS AND TREATMENT OF VENTILATED HOSPITAL-ACQUIRED PNEUMONIA IN PATIENTS WITH EXTENDED-SPECTRUM BETA-LACTAMASE-PRODUCING ENTEROBACTERALES RECTAL CARRIAGE." ANNALS OF INTENSIVE CARE, VOL. 14, NO. 1, 29 JULY 2024, HTTPS://DOI.ORG/10.1186/S13613-024-01348-5. CONCLUSION: N/A FOR INITIAL REPORT.
SUMMARY: A PUBLICATION BY BAY ET AL. "PERFORMANCE AND IMPACT OF RAPID MULTIPLEX PCR ON DIAGNOSIS AND TREATMENT OF VENTILATED HOSPITAL-ACQUIRED PNEUMONIA IN PATIENTS WITH EXTENDED-SPECTRUM BETA-LACTAMASE-PRODUCING ENTEROBACTERALES RECTAL CARRIAGE" STATED THERE WERE DISCORDANT CTX-M RESULTS BETWEEN THE FILMARRAY PNEUMONIA PANEL PLUS AND CONVENTIONAL CULTURE. ACCORDING TO "SUPPLEMENTARY 2" FROM THE PUBLICATION, A PATIENT WITH A DISCORDANT CTX-M RESULT RECEIVED MEROPENEM PLUS AMIKACIN AS EMPIRICAL ANTIBIOTIC THERAPY. THE OUTCOME OF THE PATIENT WAS UNFAVORABLE, AND THEY PASSED AWAY WITHIN 48 HOURS DUE TO MULTIORGAN FAILURE. BIOFIRE REQUESTED FURTHER INFORMATION FROM THE AUTHOR TO CLARIFY WHETHER THE FILMARRAY PNEUMONIA PANEL PLUS RESULT CONTRIBUTED TO THE PATIENT'S DEATH, HOWEVER, DESPITE MULTIPLE ATTEMPTS, BIOFIRE WAS UNABLE TO RECEIVE FURTHER INFORMATION FROM THE AUTHOR. THE INVESTIGATION DETERMINED THAT THE STUDY USED A PRETREATED SAMPLE, WHICH IS AN OFF-LABEL SAMPLE TYPE, AND DEVIATED FROM THE INTENDED USE OF THE FILMARRAY PNEUMONIA PANEL PLUS. PLEASE NOTE CHECK BOX FOR "DEATH" WAS SELECTED ON SECTION B2 (OUTCOMES ATTRIBUTED TO ADVERSE EVENT) AND SECTION H1 (TYPE OF REPORTABLE EVENT) IN THE INITIAL MDR OUT OF AN ABUNDANCE OF CAUTION. UPON REVIEW BY THE BIOFIRE MEDICAL AFFAIRS TEAM, IT WAS DETERMINED THAT IT IS HIGHLY UNLIKELY THAT THE FILMARRAY PNEUMONIA PANEL PLUS RESULT CONTRIBUTED TO THE PATIENT'S DEATH. THEREFORE, SECTION B2 WAS CHANGED TO "OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS" FOR THIS FINAL REPORT AND A CHECK BOX WAS NOT SELECTED FOR SECTION H1.
SUMMARY: DISCORDANT CTX-M RESULTS BETWEEN THE FILMARRAY PNEUMONIA PANEL PLUS AND CONVENTIONAL CULTURE WERE MENTIONED IN A PUBLICATION BY BAY ET AL. TITLED "PERFORMANCE AND IMPACT OF RAPID MULTIPLEX PCR ON DIAGNOSIS AND TREATMENT OF VENTILATED HOSPITAL-ACQUIRED PNEUMONIA IN PATIENTS WITH EXTENDED-SPECTRUM BETA-LACTAMASE-PRODUCING ENTEROBACTERALES RECTAL CARRIAGE." A PATIENT WITH A DISCORDANT CTX-M RESULT RECEIVED MEROPENEM PLUS AMIKACIN AS EMPIRICAL ANTIBIOTIC THERAPY AFTER THE FILMARRAY PNEUMONIA PANEL PLUS RESULT. THE OUTCOME OF THE PATIENT WAS NOTED AS UNFAVORABLE, AND THEY PASSED AWAY WITHIN 48 HOURS DUE TO MULTIORGAN FAILURE. IT IS UNKNOWN IF THE FILMARRAY PNEUMONIA PANEL PLUS RESULT CONTRIBUTED TO THE PATIENT'S DEATH. BIOFIRE IS SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE AUTHOR AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME. PLEASE NOTE THAT THE PATIENT'S ENDOTRACHEAL SAMPLE THAT WAS TESTED ON THE FILMARRAY PNEUMONIA PANEL PLUS HAD BEEN PRE-TREATED WITH A MUCOLYTIC SOLUTION. TREATING A FILMARRAY PNEUMONIA PANEL PLUS SAMPLE WITH A MUCOLYTIC SOLUTION IS CONSIDERED AN OFF-LABEL USE OF THE PANEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1793389 | FILMARRAY® PNEUMONIA PANEL PLUS | FILMARRAY® PNEUMONIA PANEL PLUS | QDS | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0143 | 00815381020314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| D |