BD PANEL PHOENIX NMIC-311
Report
- Report Number
- 1119779-2024-00547
- Event Type
- Malfunction
- Date Received
- July 9, 2024
- Date of Event
- June 19, 2024
- Report Date
- October 11, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904494520
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4072183, D4. MEDICAL DEVICE EXPIRATION DATE: 29-MAR-2025, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), H4. DEVICE MANUFACTURE DATE: 12-MAR-2024. D4. MEDICAL DEVICE LOT #: 4128500, D4. MEDICAL DEVICE EXPIRATION DATE: 10-MAY-2025, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), H4. DEVICE MANUFACTURE DATE: 07-MAY-2024. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR INVALID MIC RESULTS FOR CEFTOLOZANE-TAZOBACTAM (CT) WITH ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBERS 4072183 AND 4128500. THE CUSTOMER DID NOT PROVIDE ISOLATES, OR PANEL RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE LAB REPORTS SHOW NO MIC RESULTS FOR CT WITH E. COLI WHEN USING THE COMPLAINT BATCHES. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCHES WERE INOCULATED WITH IN HOUSE ISOLATES E. COLI 22811, E. COLI 22812, AND E. COLI 22851 TO OBSERVE FOR CT MIC RESULTS. ADDITIONALLY, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES E. COLI 22811, E. COLI 22812, AND E. COLI 22851 TO OBSERVE FOR CT MIC RESULTS. THE INVESTIGATION RETURNED MIC RESULTS FOR CT; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. 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.
UNKNOWN LOT NUMBER: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H.4. DEVICE MANUFACTURE DATE: UNKNOWN. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. PMA / 510(K)#: K020322 K022129 K023444 K023634 K023858 K024153 K031530 K031699 K031912 K032299 K032567 K032655 K033362 K033560 K041384 K042932 K052269 K060214 K060217 K060257 K060444 K060447 K061327 K061355 K062207 K062944 K063301 K063486 K063573 K063811 K063824 K071623 K123404 K132674 K132909 K151320 K173252 K190905 K163637 K173523 K033458 AND K123266. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING THE BD PANEL PHOENIX NMIC-311AN UNSPECIFIED NUMBER OF PATIENT SAMPLES RESULTED IN NO MIC FOR THE DRUG CEFTOLOZANE/TAZOBACTAM (C/T). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PANEL PHOENIX NMIC-311AN UNSPECIFIED NUMBER OF PATIENT SAMPLES RESULTED IN NO MIC FOR THE DRUG CEFTOLOZANE/TAZOBACTAM (C/T). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 544714 | BD PANEL PHOENIX NMIC-311 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | UNKNOWN | 00382904494520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |