MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for ENDOTOOL manufactured by Monarch.
[104467800]
Utilizing insulin algorithm software (monarch endotool) a pt was administered insulin 9 units as recommended by endotool. The pt was hypokalemic, potassium replacement was started simultaneously with initiation of insulin. The pt was transferred to the icu for dka management, he became unresponsive and coded due to an unstable cardiac arrythmia. Post code the pt was found to have critically low potassium level which contributed to the code.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076287 |
| MDR Report Key | 7395366 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-01-04 |
| Date Added to Maude | 2018-04-04 |
| 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 | ENDOTOOL |
| Generic Name | ENDOTOOL |
| Product Code | NDC |
| Date Received | 2018-04-03 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONARCH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-04-03 |