FDA Adverse Event
Malfunction
Summary report: N
BD PHOENIX¿ NMIC/ID-307
MDR report key: 25085981
·
Received May 5, 2026
Report
- Report Number
- 1119779-2026-00763
- Event Type
- Malfunction
- Date Received
- May 5, 2026
- Date of Event
- April 14, 2026
- Report Date
- April 26, 2026
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA /510(K)#: G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, 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.
Description of Event or Problem · 0
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS ENTEROBACTER CLOACAE. THE USER VERIFIED THE FINAL RESULT USING MALDI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97224 | BD PHOENIX¿ NMIC/ID-307 | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4100148 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |