MAUDE Adverse Event Report: MEDICAL DECISION NETWORK GLUCOSTABILIZER; CALCULATOR, DRUG DOSE

Model Number V3.5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Mdn was working to set up out prodcition account; this is our first electronic report and was delayed due to the signup process.(b)(6).

Event Description

Sk alleged that she was in moses h cone hospital as a patient from (b)(6) through (b)(6) 2020.She stated she has type 1 diabetes and was on glucostabilizer during her stay and that she went into diabetic ketoacidosis (dka) 2 times.Initial investigation showed that glucostabilizer did not malfunction; the multiplier and calculated insulin infusion rates performed per the algorithm and the configured settings by moses cone.All configuration settings appeared appropriate.The glucose entries appeared timely.The blood glucose values entered into glucostabilizer for sk were not typical for dka, however euglycemic (near normal or mildly elevated blood glucose levels) dka can occur.After speaking with the client, moses cone, it was learned that sk was hospitalized with a diagnosis of dka and prior to the dka admission sk medication regimen included a sodium-glucose cotransporter (sglt) inhibitor.

• Brand Name: GLUCOSTABILIZER
• Type of Device: CALCULATOR, DRUG DOSE
• Manufacturer (Section D): MEDICAL DECISION NETWORK; 2220 ivy road; suite 403; charlottesville VA 22903
• Manufacturer Contact: brandon rose ; 2220 ivy road; suite 403; charlottesville, VA 22903 ; 4349510005
• MDR Report Key: 10856065
• MDR Text Key: 216846077
• Report Number: 3010817588-2020-00001
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V3.5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 63