BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1)
Report
- Report Number
- 3002773840-2025-00074
- Event Type
- Injury
- Date Received
- September 30, 2025
- Report Date
- October 31, 2025
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- QOF
- UDI-DI
- 00815381020529
- PMA / PMN Number
- DEN200031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: THE CUSTOMER INFORMED BIOFIRE THAT THE VACUUM SEAL ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) CANISTERS WERE EXTREMELY TIGHT, MAKING IT DIFFICULT TO REMOVE THE PRODUCT FROM THE PACKAGING. THE CUSTOMER STATED THAT IN SOME CASES STAFF HAVE HAD TO PUSH THE CANISTER OUT FROM THE BOTTOM, REQUIRING SIGNIFICANT FORCE. THE CUSTOMER REPORTED THIS HAS LED TO MUSCULOSKELETAL STRAIN AMONG EMPLOYEES, WITH THREE INDIVIDUALS CURRENTLY BEING TREATED FOR CARPAL TUNNEL AND OTHER RELATED INJURIES. SPECIFIC DETAILS REGARDING THESE INDIVIDUALS HAVE NOT BEEN PROVIDED AT THIS TIME. BIOFIRE IS SUBMITTING THREE INDIVIDUAL MDRS, ONE FOR EACH AFFECTED INDIVIDUAL AS REPORTED BY THE CUSTOMER. THIS MDR PERTAINS TO INDIVIDUAL #3. BIOFIRE'S INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FSCA HAS BEEN DEEMED NECESSARY AT THIS TIME. CONCLUSION: N/A FOR INITIAL REPORT.
INVESTIGATION: THE CUSTOMER REPORTED BIOFIRE RP2.1 CANISTERS WERE EXTREMELY TIGHT, MAKING IT DIFFICULT TO REMOVE THE PRODUCT FROM THE PACKAGING AND IN SOME CASES STAFF HAVE HAD TO PUSH THE CANISTER OUT FROM THE BOTTOM, REQUIRING SIGNIFICANT FORCE. THE CUSTOMER REPORTED THIS LED TO MUSCULOSKELETAL STRAIN AMONG EMPLOYEES, WITH THREE INDIVIDUALS CURRENTLY BEING TREATED FOR CARPAL TUNNEL AND OTHER RELATED INJURIES. THE EMPLOYEES THAT REPORTED ERGONOMIC INJURIES WERE OPENING APPROXIMATELY 8 TO 10 CANISTERS PER DAY. SPECIFIC DETAILS REGARDING THESE INDIVIDUALS WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE EMPLOYEES REQUIRED ADDITIONAL MEDICAL INTERVENTION DUE TO THE INJURIES. BIOFIRE ASKED THE CUSTOMER WHETHER THEY CONTINUE TO EXPERIENCE ISSUES WITH BIOFIRE RP2.1 CANISTERS BEING EXTREMELY TIGHT, WHICH LOT FIRST EXHIBITED THE PROBLEM, AND ANY ADDITIONAL AFFECTED LOTS. DESPITE MULTIPLE ATTEMPTS, BIOFIRE WAS UNABLE TO RECEIVE THE REQUESTED INFORMATION. CONCLUSION: THE INVESTIGATION HAS DOCUMENTED THE INJURIES OCCURRING DURING POUCH LOADING. THIS ISSUE IS LIKELY NOT DUE TO A SPECIFIC LOT, AND IT IS NOT SUSPECTED THAT THERE WAS AN ISSUE WITH THE BIOFIRE PRODUCT. THE CUSTOMER SHOULD FOLLOW THE "PROCEDURE" SECTION OF THE BIOFIRE RP2.1 INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0105) AND THE APPROPRIATE QUICK GUIDE FOR POUCH LOADING PROCEDURES. THE "PROCEDURE" SECTION OF THE BIOFIRE RP2.1 IFU STATES TO REMOVE THE POUCH FROM ITS VACUUM-SEALED PACKAGE BY TEARING OR CUTTING THE NOTCHED OUTER PACKAGING AND OPENING THE PROTECTIVE CANISTER. FOR ADDITIONAL INSTRUCTIONS ON OPENING THE MYLAR BAG, THE CUSTOMER CAN ASK EMPLOYEES TO USE A CUTTING DEVICE SUCH AS SCISSORS TO FINISH OPENING THE BAG WHEN THE MYLAR BAG FAILS TO TEAR COMPLETELY. OR A SECONDARY TEAR ACROSS THE TOP OF THE MYLAR BAG MAY BE MADE. BIOFIRE RECOMMENDS THAT CUSTOMERS DO NOT TRY TO RIP DOWN THE SIDES OF THE MYLAR BAG. THE SIDES OF THE MYLAR BAG MAY BE OPENED BY USING A CUTTING DEVICE SUCH AS SCISSORS. IF TEAR ACROSS THE TOP IS NECESSARY, PUSHING THE CAN OUT OF THE BAG IS NOT RECOMMENDED, AS THE CUSTOMER REPORTED THE FORCE REQUIRED TO DO THIS CAN CAUSE INJURIES.
SUMMARY: (B)(6) INFORMED BIOFIRE THAT THE VACUUM SEAL ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) CANISTERS WERE EXTREMELY TIGHT, MAKING IT DIFFICULT TO REMOVE THE PRODUCT FROM THE PACKAGING. THE CUSTOMER STATED THAT IN SOME CASES STAFF HAVE HAD TO PUSH THE CANISTER OUT FROM THE BOTTOM, REQUIRING SIGNIFICANT FORCE. THE CUSTOMER REPORTED THIS HAS LED TO MUSCULOSKELETAL STRAIN AMONG EMPLOYEES, WITH THREE INDIVIDUALS CURRENTLY BEING TREATED FOR CARPAL TUNNEL SYNDROME AND OTHER RELATED INJURIES. SPECIFIC DETAILS REGARDING THESE INDIVIDUALS HAVE NOT BEEN PROVIDED AT THIS TIME. BIOFIRE IS SUBMITTING THREE INDIVIDUAL MEDICAL DEVICE REPORTS (MDRS), ONE FOR EACH AFFECTED INDIVIDUAL AS REPORTED BY THE CUSTOMER. THIS MDR (3002773840-2025-00074) PERTAINS TO INDIVIDUAL #3. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER 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.
SUMMARY: (B)(6) INFORMED BIOFIRE THAT THE VACUUM SEAL ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) CANISTERS WERE EXTREMELY TIGHT, MAKING IT DIFFICULT TO REMOVE THE PRODUCT FROM THE PACKAGING. THE CUSTOMER STATED THAT IN SOME CASES STAFF HAVE HAD TO PUSH THE CANISTER OUT FROM THE BOTTOM, REQUIRING SIGNIFICANT FORCE. THE CUSTOMER REPORTED THIS HAS LED TO MUSCULOSKELETAL STRAIN AMONG EMPLOYEES, WITH THREE INDIVIDUALS CURRENTLY BEING TREATED FOR CARPAL TUNNEL SYNDROME AND OTHER RELATED INJURIES. SPECIFIC DETAILS REGARDING THESE INDIVIDUALS WERE NOT PROVIDED. BIOFIRE IS SUBMITTING THREE INDIVIDUAL MEDICAL DEVICE REPORTS (MDRS), ONE FOR EACH AFFECTED EMPLOYEE AS REPORTED BY THE CUSTOMER. THIS MDR (3002773840-2025-00074) PERTAINS TO INDIVIDUAL #3. THE INVESTIGATION HAS DOCUMENTED THE INJURIES OCCURRING DURING BIOFIRE RP2.1 POUCH LOADING. THIS ISSUE IS LIKELY NOT DUE TO A SPECIFIC LOT, AND IT IS NOT SUSPECTED THAT THERE WAS AN ISSUE WITH THE BIOFIRE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1674061 | BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1) | BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1) | QOF | BIOFIRE DIAGNOSTICS, LLC | 423742 | N/A | 00815381020529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |