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	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the meter is not passing low solution testing.The high solution qc test is passing just fine; only the low qc test is failing consistently.
Additional Manufacturer Narrative
It was reported that the item was not passing low solution, and the customer reported that the meter is not passing low solution testing while the high solution qc test is passing just fine and only the low qc test is failing consistently.Medline received an evencare g3 blood glucose monitor level 1 control solution; visual inspection found nothing out of place, the expiration date was still good as of 1/11/2024, and the color of solution and overall appearance of the bottle itself was fine.Upon further testing, medline compared new level 1 and level 3 control solutions; the new controlled solutions both met the criteria, and when testing the level 1 solution that was sent in, it showed lower numbers then needed to meet the criteria.The complaint was confirmed, a cause code of "comp./part defective, broke" was recorded, and no further action was taken because objectionable trends were not seen for this issue.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: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883462
• Report Number: 1417592-2026-49832
• Device Sequence Number: 10667595
• Product Code: CGA
• UDI-Device Identifier: 10884389831199
• UDI-Public: 10884389831199
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/23/2026

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: MPH3540
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2024
• 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: 01/02/2024
• 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