MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for UNKNOWN manufactured by Unk.
[132795567]
In 2018 prescription for singulair 10mg ran through for a pt and reversed about 10 seconds later. Not sure why this occurred but it still triggers our robot to count the medication. Around the same time period, a prescription was generated for singulair 5mg for a different pt. This strength is not counted by the robot. The robot singulair 10mg was then placed in the wrong pts bag. The error was not noticed for 27 days out of 30. The pt called and noticed they had the incorrect medication. A replacement bottle was given and toxicity info looked safe and no adverse events were reported. This was missed clearly and illustrates a new level of automated potential drug errors. A multi point checking standard still needs to be adhered which verifies but is not limited to the medication and what is in the bottle and whom it is labeled for. (b)(6), access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083011 |
| MDR Report Key | 8231832 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-01-01 |
| Date Added to Maude | 2019-01-09 |
| 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 | UNKNOWN |
| 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 | UNKNOWN |
| Generic Name | DISPENSER, SOLID MEDICATION |
| Product Code | NXB |
| Date Received | 2019-01-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-08 |