MAUDE Adverse Event Report: GLYTEC, LLC GLUCOMMANDER; ELECTRONIC GLYCEMIC MANAGEMENT SYSTEM (EGMS)

Model Number	3.5.1.2
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Glytec received a call from a healthcare professional who was attempting to modify a patient's recommended basal dosages and dose frequency.Upon doing so, the new basal dose recommendation was higher than the nurse expected.This dose was not administered to the patient and no adverse events necessitating medical intervention were reported.
Additional Manufacturer Narrative
An uncommon workflow in glucommander subq v3.5.1.2 or later, e.G., delivering basal dose many hours late and changing the dose distribution, may result in a planned guardrail to not function as intended resulting in a higher than expected basal dose recommendation.This was observed to occur once in 100s of 1000s of basal dose recommendations.This issue was addressed in software patch 3.5.2.2, released april 27, 2023 and implemented by the customer may 6, 2023.This mdr was initially submitted through esg on 08-feb-2023 as "fda mdr 08-feb-2023 final version.Pdf".On 25-sep-2024, it came to glytec's attention that the emdr had failed to load successfully into the cdrh adverse event database.Hence, glytec contacted cesub help desk on 25-sep-2024 to inquire why the submission on 08-feb-2023 failed.Cesub help logged glytec's inquiry as csh-36933.On 01-oct-2024, cesub responded to glytec stating: "the submitted pdf file as the submission file but the submission file has to be a zip file that's created using esubmitter.Please advise the user to use esubmitter to create their submission." therefore, glytec is going to re-submit this mdr via esg after re-creating it (this report you are reading now) using esubmitter.

• Brand Name: GLUCOMMANDER
• Common Device Name: ELECTRONIC GLYCEMIC MANAGEMENT SYSTEM (EGMS)
• Manufacturer (Section D): GLYTEC, LLC; 220 north main st; greenville SC 29601
• Manufacturer (Section G): GLYTEC, LLC; 220 north main st; greenville SC 29601
• Manufacturer Contact: rachel hofmann ; 220 main st; greenville, SC 29601 ; 8643703297
• MDR Report Key: 20526568
• Report Number: 3005853093-2024-00001
• Device Sequence Number: 8078367
• Product Code: NDC
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.5.3.0
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.5.1.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown