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U.S. Department of Health and Human Services

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

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MEDICAL DECISION NETWORK GLUCOSTABILIZER INSULIN DRIP TITRATION SOFTWARE Back to Search Results
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.
 
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Brand NameGLUCOSTABILIZER
Type of DeviceINSULIN DRIP TITRATION SOFTWARE
Manufacturer (Section D)
MEDICAL DECISION NETWORK
MDR Report Key6906754
MDR Text Key88029330
Report NumberMW5072548
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Number of Events Reported1
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 Received10/02/2017
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
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