PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2024-00800
- Event Type
- Malfunction
- Date Received
- November 4, 2024
- Date of Event
- October 6, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- K181665
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: THIS IS THE 2ND LOT IN THE COMPLAINT. D4. MEDICAL DEVICE LOT #: 4191751 D4. MEDICAL DEVICE EXPIRATION DATE: 2025-JUL-05 H4. DEVICE MANUFACTURE DATE: 2024-JUL-09 D.4 UDI#: (B)(6). INVESTIGATION SUMMARY THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBERS 4197151 AND 4205932. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED ISOLATES, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW VARIOUS IDENTIFICATIONS WHEN USING THE COMPLAINT BATCHES. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS PROTEUS MIRABILIS CE45C, PROVIDENCIA STUARTII CE191, PROTEUS MIRABILIS CE2EO, ACINETOBACTER URSINGII CE2E8, SERRATIA MARCESCENS CE511, PROVIDENCIA STUARTII CE161A, PROTEUS MIRABILIS CE9F1, PROTEUS MIRABILIS CE512, PROTEUS MIRABILIS CE3E1 AND CITROBACTER FREUNDII CE3DF. TO INVESTIGATE, ONE RETENTION PANEL EACH FROM EACH OF THE COMPLAINT BATCHES WERE TESTED USING CUSTOMER RETURNED ISOLATES PROTEUS MIRABILIS CE45C, PROVIDENCIA STUARTII CE191, PROTEUS MIRABILIS CE2EO, ACINETOBACTER URSINGII CE2E8, SERRATIA MARCESCENS CE511, PROVIDENCIA STUARTII CE161A, PROTEUS MIRABILIS CE9F1, PROTEUS MIRABILIS CE512, PROTEUS MIRABILIS CE3E1 AND CITROBACTER FREUNDII CE3DF ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES PROTEUS MIRABILIS CE45C, PROVIDENCIA STUARTII CE191, PROTEUS MIRABILIS CE2EO, ACINETOBACTER URSINGII CE2E8, SERRATIA MARCESCENS CE511, PROVIDENCIA STUARTII CE161A, PROTEUS MIRABILIS CE9F1, PROTEUS MIRABILIS CE512, PROTEUS MIRABILIS CE3E1 AND CITROBACTER FREUNDII CE3DF ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 4205932. B5. IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307, AN UNKNOWN NUMBER OF PATIENT SAMPLES WERE INCORRECTLY IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES ARE MISIDENTIFIED AS E. COLI. THE RESULTS ARE BEING CONFIRMED AS PROTEUS MIRABILIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES ARE MISIDENTIFIED AS E. COLI. THE RESULTS ARE BEING CONFIRMED AS PROTEUS MIRABILIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-(B)(6), AN UNKNOWN NUMBER OF PATIENT SAMPLES WERE INCORRECTLY IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773805 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 4205932 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |