MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-24 for BD PHOENIX? NMIC-402 448874 manufactured by Becton, Dickinson & Co..
[184757962]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[184757963]
On march 2, 2020 the customer reported a false sensitive result with the bd phoenix? Nmic-402 panel. A panel was setup on (b)(6) 2020 from a swab of the patient? S leg wound. The patient? S leg was amputated on (b)(6) 2020 when the result came back for enterobacter cloacae; sensitive for amikacin. The clinician immediately started treatment with amikacin on (b)(6) 2020 to (b)(6) 2020 and sample was sent to the national reference center. On february 27, 2020 the result came back; enterobacter cloacae, resistant for amikacin. The patient died on (b)(6) 2020 but it is unclear if the patient died due to the incorrect treatment or general condition of patient due to severity of other diseases when he came into the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2020-00011 |
| MDR Report Key | 9874701 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PHOENIX? NMIC-402 |
| Generic Name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Product Code | LON |
| Date Received | 2020-03-24 |
| Catalog Number | 448874 |
| Lot Number | 9260974 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-24 |