MAUDE Adverse Event Report: AGAMATRIX, INC. MEIJER ESSENTIAL BLOOD GLUCOSE MONITORING SYSTEM

Model Number	8000-07055
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested but was not returned for investigation.Manufacturing tests were reviewed for the device involved in the incent and no issues were found.The meter left the factory within specification.Testing conditions are unknown.The owner's guide and previous field returns have been reviewed.It is not clear as to how long after the initial measurement the symptoms were experienced or the comparison measurement was made.There is no evidence from previous field returns the event was caused by a meter malfunction.Based on the information provided, the root cause of the hypoglycemic event or of the reported high measurement, compared to the patient's symptoms and a comparison measurement cannot be determined.Environmental factors such as storage and testing conditions, medical conditions, testing practices and medication could have contributed.No corrective action will be performed as no defects were identified.This complaint will continue to be trended.
Event or Problem Description
Caller says the patient's meijer essential blood glucose meter, which was recently purchased was reading 170 mg/dl/180 mg/dl.Then started patient started feeling ill (time from measurement to onset of symptoms unknown) and an ambulance was called.Emts measured blood glucose (bgm brand not reported or time between this measurement and those with the meijer essential is not known), 34 mg/dl.Patient has been in the hospital for 4 days.The reporter went to meijer but the pharmacist could not help and suggested to contact agamatrix customer service.The caller was frustrated because the pharmacist showed no compassion or empathy, felt like he was dismissed.

• Brand Name: MEIJER ESSENTIAL BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): AGAMATRIX, INC.; 7c raymond ave; salem NH 03079
• Manufacturer Contact: dave valcourt ; 7c raymond ave; salem, NH 03079 ; 6033286000
• MDR Report Key: 21167318
• Report Number: 3004637226-2025-00001
• Device Sequence Number: 18508619
• Product Code: NBW
• UDI-Device Identifier: 00760236150350
• UDI-Public: 00760236150350
• Combination Product (Y/N): N
• PMA/510(K) Number: K072413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 8000-07055
• Device Catalogue Number: 8000-07055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown