MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for GLUCOSTABILIZER manufactured by Medical Decision Network.
[88017163]
Glucostabilizer produces extremely high doses when accurate glucose levels are entered. Work around in instructions to not enter doses over 500-600, but staff entered accurate dose, resulting in drip rate over 17 units/hr. There should be a safeguard in the program so accurate pt info doesn't result in unsafe dose errors. We have seen this problem repeatedly, which can result in unsafe rates of decline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072547 |
| MDR Report Key | 6906752 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-29 |
| Date Added to Maude | 2017-10-02 |
| 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 | GLUCOSTABILIZER |
| Generic Name | INSULIN DRIP TITRATION SOFTWARE |
| Product Code | NDC |
| Date Received | 2017-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DECISION NETWORK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-02 |