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.
[88029330]
The glucostabilizer insulin drip software generates unsafe doses when high glucose values are entered. As a work-around, they recommend users not to enter values above 500-600 mg/dl. The program increases the drip with each adjustment regardless of pt response. The doses will always be 8. 8, 13. 2, and 17. 6 units/hr when an arbitrary value of "500" is entered, and doses of 10. 8, 16. 2, and 21. 6 when a value of "600" is entered. This has repeatedly resulted in very rapid glucose changes. Many cases of overly rapid correction (goal approx 100mg/dl/hr). We have noticed very rapid declines in potassium which affect the heart, headache, and nausea/vomiting, and decreased loc to which this may have contributed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072548 |
| MDR Report Key | 6906754 |
| 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 | 0 |
| 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 | N |
| 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. Life Threatening; 2. Other; 3. Required No Informationntervention | 2017-10-02 |