MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-08 for ELECTRONIC MEDICAL RECORD manufactured by Epic.
[40235636]
There was a deep vein thrombosis afflicting this pt, for which he was being treated with coumadin. An inr was deposited into the electronic care record device without notice or warning. It was elevated and required that coumadin not be administered, but, no one saw the result that was silent in the coag silo. Consequently, the usual dose of coumadin was administered that resulted in an tnr that was markedly elevated, that required immediate reversal. There was a 5 gram decreased in hemoglobin that threatened the life and well being of this pt. It is a widespread problem in ehr driven care that disease critical results come back silently, and sometimes such is deadly. Oversight and correction of this defect is indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060847 |
| MDR Report Key | 5495524 |
| Date Received | 2016-03-08 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-03-06 |
| Date Added to Maude | 2016-03-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELECTRONIC MEDICAL RECORD |
| Generic Name | MDDS/EHR |
| Product Code | NSX |
| Date Received | 2016-03-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPIC |
| Manufacturer Address | VERONA WI 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2016-03-08 |