BD PANEL PHOENIX NMIC-311
Report
- Report Number
- 1119779-2023-01271
- Event Type
- Malfunction
- Date Received
- November 29, 2023
- Date of Event
- November 5, 2023
- Report Date
- April 11, 2024
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904494520
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G.5. PMA/510(K)#: THE PANEL PHOENIX NMIC/ID-311 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447, K032567, K060257, K023634, K123404, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B3: DATE OF EVENT: (B)(6) 2023 B5: DESCRIBE EVENT: IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT URINE ISOLATE (504411468182) WAS RESULTED AS POSITIVE FOR EXTENDED SPECTRUM BETA-LACTAMASE (ESBL). THE RESULT WAS CONFIRMED TO BE NEGATIVE BY KIRBY BAUER CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 4. B6: RELEVANT TESTS/LABORATORY DATA: BACTERIAL CULTURE - KIRBY BAUER. D4. MEDICAL DEVICE LOT #: 3241410. D.4. MEDICAL DEVICE EXPIRATION DATE: 24-AUG-2024. H.4. DEVICE MANUFACTURE DATE: 29-AUG-2023.
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: REPORT 1 OF 4. IT WAS REPORTED THAT DURING USE OF THE BD PANEL PHOENIX NMIC-311, THERE WAS FALSE POSITIVE ESBL ON K. OXYTOCA. THERE WAS NO ADVERSE IMPACT TO PATIENT REPORTED.
THE FOLLOWING INFORMATION HAS BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL? YES. D.9. RETURNED TO MANUFACTURER ON: 10-NOV-2023. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE POSITIVE ESBL RESULTS WITH KLEBSIELLA OXYTOCA WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBERS 3241410 AND 3202514. THE CUSTOMER DID NOT PROVIDE ISOLATE RETURNS BUT PROVIDED PANEL RETURNS AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW POSITIVE ESBL RESULTS FOR K. OXYTOCA FROM A URINE AND SPUTUM SAMPLE WHEN USING THE COMPLAINT BATCH. IT IS TO BE NOTED THAT BATCH 3202514 IS AN ID ONLY PANEL AND THEREFORE DOES NOT TEST FOR ESBL RESULTS AND WAS NOT USED IN INVESTIGATION TESTING. TO INVESTIGATE, THREE CUSTOMER RETURNED PANELS EACH FROM COMPLAINT BATCH 3241410 WERE INOCULATED WITH IN HOUSE ISOLATES K. OXYTOCA 18410 AND K. OXYTOCA 18411 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR ESBL RESULTS. ADDITIONALLY, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES K. OXYTOCA 18410 AND K. OXYTOCA 18411 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR ESBL RESULTS. DURING THE INVESTIGATION TESTING, THE EIGHT PANELS TESTED DID NOT RETURN ESBL POSITIVE RESULTS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORDS WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. A REVIEW OF COMPLAINTS REVEALED NO OTHER COMPLAINTS ON THIS BATCH. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.
IT HAS BEEN REPORTED THAT THREE BD PANEL PHOENIX NMIC-311 HAS BEEN FOUND GIVING FALSE POSITIVE RESULTS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE ESBL REPORTED. CUSTOMER DOES NOT BELIEVE THERE WERE ANY ADVERSE PATIENT AFFECTS.
IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT URINE ISOLATE (504411468182) WAS RESULTED AS POSITIVE FOR EXTENDED SPECTRUM BETA-LACTAMASE (ESBL). THE RESULT WAS CONFIRMED TO BE NEGATIVE BY KIRBY BAUER CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 4.
REPORT 1 OF 4. IT WAS REPORTED THAT DURING USE OF THE BD PANEL PHOENIX NMIC-311, THERE WAS FALSE POSITIVE ESBL ON K. OXYTOCA. THERE WAS NO ADVERSE IMPACT TO PATIENT REPORTED.
IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT URINE ISOLATE (504411468182) WAS RESULTED AS POSITIVE FOR EXTENDED SPECTRUM BETA-LACTAMASE (ESBL). THE RESULT WAS CONFIRMED TO BE NEGATIVE BY KIRBY BAUER CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 982661 | BD PANEL PHOENIX NMIC-311 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON, DICKINSON & CO. (SPARKS) | 3241410 | 00382904494520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |