MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; METER,GLUCOSE,EVENCARE G3,PROF.USE ONLY

Catalog Number	MPH3540
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we are using the evencare g3 blood glucose test strips, running the evencare g3 glucose control solutions and getting incorrect numbers that are not in range.".
Additional Manufacturer Narrative
The customer reported getting incorrect numbers that are not in range while using the evencare g3 blood glucose test strips and running the evencare g3 glucose control solutions.The glucose monitor was visually inspected before functional testing was conducted, and no signs of physical damage, wear, or defects were observed; functional evaluation was performed using both the customer provided evencare test strips and control solutions, as well as on hand evencare control test strips and control solutions.Based on the sample evaluation, the control solution supplied by the customer was not in range, while the glucose monitor reported as affected functioned as intended as the on hand evencare control solutions were within the specified ranges.It is difficult to determine an exact cause as it is unknown what could have contributed to the issue, and the division will monitor this issue for trending purposes.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 G3,PROF.USE ONLY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50859618
• Report Number: 1417592-2026-48235
• Device Sequence Number: 13136181
• Product Code: NBW
• UDI-Device Identifier: 10884389831199
• UDI-Public: 10884389831199
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120448
• 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): 09/22/2026

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: MPH3540
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2026
• 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: 03/11/2026
• Initial Report FDA Received Date: 09/22/2026
• 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