MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; METER, GLUCOSE, EVENCARE G2

Catalog Number	MPH1540
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the meter is providing consistent out of ranges.".
Additional Manufacturer Narrative
The customer states the meter is providing consistent out of ranges and confirmed solution is not expired.Medline received 1ea evencare g2 blood glucose meter in used condition; test strips and control solutions used by the user were not sent for the investigation, and testing was performed according to the instructions for use using control test strips and control solutions.Results using the control strips and solutions were 55 and 196mg/dl for low and high solutions respectively, which were within control solutions range of 41-71 mg/dl and 167-227 mg/dl; the sample turned on/off and control solution results were within testing range.The complaint was not confirmed, no root cause was identified, and the division will continue to monitor trends.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: METER, GLUCOSE, EVENCARE G2
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884711
• Report Number: 1417592-2026-50068
• Device Sequence Number: 10704829
• Product Code: NBW
• UDI-Device Identifier: 00884389102551
• UDI-Public: 00884389102551
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Catalogue Number: MPH1540
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown