MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for ECLINICALWORKS manufactured by Eclinicalworks.
[106703658]
We reported a new issue with eclinicalworks with the newest version 11 on (b)(6) related to prescriptions. The issue occurs when a decimal point is typed in a dosage. For example, if a provider is prescribing 2. 5 ml twice a day, when the dose is typed, the decimal point is immediately removed by the software. If this is not noticed by the provider who is typing in the dose, it could result in a 10 fold or even 100 fold dosing error in the case of something like 1. 25 ml. This could be potentially fatal depending on the medication being prescribed if it is not detected. We entered the case on (b)(6) and to date there has been no solution offered and the issue still exists, leaving the door open for potentially severe pt safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076691 |
| MDR Report Key | 7457694 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-20 |
| Date Added to Maude | 2018-04-25 |
| 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 |
| 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 | ECLINICALWORKS |
| Generic Name | MEDICAL COMPUTERS AND SOFTWARE |
| Product Code | LNX |
| Date Received | 2018-04-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECLINICALWORKS |
| Manufacturer Address | 2 TECHNOLOGY DR. WESTBOROUGH MA 01581 US 01581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-24 |