MAUDE Adverse Event Report: MEDICAL DECISION NETWORK GLUCOSTABILIZER INSULIN DRIP TITRATION SOFTWARE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Electrolyte Imbalance (2196)

Event Type  Injury  

Event Description

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.

• Brand Name: GLUCOSTABILIZER
• Type of Device: INSULIN DRIP TITRATION SOFTWARE
• Manufacturer (Section D): MEDICAL DECISION NETWORK
• MDR Report Key: 6906754
• MDR Text Key: 88029330
• Report Number: MW5072548
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/02/2017 Patient Sequence Number: 1