MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-23 for BD MAX MRSA ASSAY manufactured by Bd.
[21451348]
Our institution uses a bd max mrsa assay for nasal swab specimens and positive blood cultures with gram positive cocci in clusters. Pt was admitted for a low hemoglobin on (b)(6). Pt was eventually found to have a hemothorax and transferred to the icu on (b)(6). Pt spiked fevers on (b)(6) and blood cultures were obtained that turned positive later that day. Gram stain of blood culture showed gram positive cocci in clusters. The specimen was run on the bd max (b)(4) assay. The assay suggested (b)(6). The icu team switched the pt from vancomycin to nafcillin. Traditional culture and sensitivity later revealed (b)(6). The pt is now under hospice care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041071 |
| MDR Report Key | 4569664 |
| Date Received | 2015-02-23 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-02-21 |
| Date Added to Maude | 2015-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD MAX MRSA ASSAY |
| Generic Name | BD MAX MRSA ASSAY |
| Product Code | NQX |
| Date Received | 2015-02-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-02-23 |