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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 Problems Application Program Problem: Dose Calculation Error (1189); Material Integrity Problem (2978)
Patient Problem Overdose (1988)
Event Type  Injury  
Event Description
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.
 
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Brand NameGLUCOSTABILIZER
Type of DeviceINSULIN DRIP TITRATION SOFTWARE
Manufacturer (Section D)
MEDICAL DECISION NETWORK
MDR Report Key6906752
MDR Text Key88017163
Report NumberMW5072547
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 an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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? No
Type of Device Usage

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