MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STARTER KIT, GLUCOSE, EVENCARE G2 1EA

Catalog Number	MPH1545
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "his gluscose monitor is not reading correctly for the low range of the test solution" and "the device is not reading within the alotted range.".
Additional Manufacturer Narrative
The customer reported receiving a medline evencare g2 glucose meter that was giving low readings during use, and no other information was available other than "not reading correctly for the low range of the test solution." medline received the meter in used condition; the sample came with no batteries, the customer did not send in the control strips or solutions they used with the sample, and medline inserted 2 aaa control batteries and tested the sample according to the instructions for use using evencare g2 glucose control solutions and evencare g2 blood glucose test strips.All test results were within control solution range; low control solution readings were 44 mg/dl and 187 mg/dl for high control solution, and during testing medline experienced no issues.The complaint was not confirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.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: STARTER KIT, GLUCOSE, EVENCARE G2 1EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50900185
• Report Number: 1417592-2026-51243
• Device Sequence Number: 14952808
• Product Code: NBW
• UDI-Device Identifier: 00884389102407
• UDI-Public: 00884389102407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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: MPH1545
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2025
• 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: 04/04/2025
• Initial Report FDA Received Date: 09/25/2026
• 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