MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-09 for ECLINICAL WORKS manufactured by .
[5380134]
(b)(6), our electronic medical record, did not update my patients list of medications. Amitriptyline was left out. This is a serious error as the patient was confused as to what medication she took. By reviewing the chart and the history and asking the patient, we were able to figure out that was indeed on amitriptyline, as well as other meds with serotonin interactions. I have no idea why amitriptyline was not on her emr at the time of being seen as it had not been discontinued, it just didn't appear. In addition ot the terrible usability problems of the emr, this error took quite a bit of effort to figure out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040267 |
| MDR Report Key | 4438647 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-09 |
| Date of Event | 2015-01-07 |
| Date Added to Maude | 2015-01-22 |
| 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 | 0 |
| 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 | ECLINICAL WORKS |
| Generic Name | ECLINICAL WORKS |
| Product Code | NSX |
| Date Received | 2015-01-09 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-09 |