BD PHOENIX¿ NMIC-311
Report
- Report Number
- 1119779-2024-00914
- Event Type
- Malfunction
- Date Received
- November 21, 2024
- Date of Event
- September 1, 2024
- Report Date
- December 11, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904494521
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES H.3 DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 06-NOV-2024 INVESTIGATION SUMMARY THIS COMPLAINT IS FOR FALSE RESISTANCE TO CARBAPENEMS WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 4233343. THE CUSTOMER PROVIDED PANEL RETURNS, ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW KLEBSIELLA PNEUMONIAE AND PROTEUS MIRABILIS WITH VARIED CARBAPENEM MICS WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF COMPLAINT BATCH 4233343 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE D1, K. PNEUMONIAE D11, P. MIRABILIS C1 AND P. MIRABILIS C2 AND EVALUATED FOR CARBAPENEM MIC RESULTS. IN ADDITION, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE D1, K. PNEUMONIAE D11, P. MIRABILIS C1 AND P. MIRABILIS C2 AND EVALUATED FOR CARBAPENEM MIC RESULTS. LAST, CUSTOMER RETURNED PANELS OF COMPLAINT BATCH 4233343 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE D1, K. PNEUMONIAE D11, P. MIRABILIS C1 AND P. MIRABILIS C2 AND EVALUATED FOR CARBAPENEM MIC RESULTS. ALL PANELS TESTED RETURNED THE EXPECTED MICS FOR CARBAPENEMS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. 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 ASSOCIATED WITH THIS DEFECT. PLEASE CONTINUE TO COMMUNICATE ADDITIONAL CONCERNS.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS (FALSE RESISTANCES) FOR CARBAPENEMS. THE USER NOTED THAT SPECIFIC DRUGS LIKE, ERTAPENEM AND MEROPENEM, ARE RESISTANT BUT ARE NOT WITH REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS (FALSE RESISTANCES) FOR CARBAPENEMS. THE USER NOTED THAT SPECIFIC DRUGS LIKE, ERTAPENEM AND MEROPENEM, ARE RESISTANT BUT ARE NOT WITH REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2427399 | BD PHOENIX¿ NMIC-311 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4233343 | 30382904494521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |