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

Catalog Number	MPH1540
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the meter is not giving corhrect readings.".
Additional Manufacturer Narrative
According to the customer, over the past "month or month and a half" the glucose meter is reading "20 points high"; the customer stated that she is diabetic but does not use insulin and also has an alternative glucose monitor from her doctor that uses, and reported there was no serious injury, medical intervention, or follow-up care related to the reported incident.At this time, a sample(s) was not received for investigation; however, a lot number/serial number was recorded, investigation included review of recent complaint trends/scar activity for the last three trend reports, and the vendor was notified.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo.No trends were identified for the specified material number and its corresponding defect type, the division will continue to monitor trends, and if the sample(s) is received at a later date, this investigation will be reopened, and additional details will be provided.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: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886453
• Report Number: 1417592-2026-50321
• Device Sequence Number: 9826715
• Product Code: NBW
• UDI-Device Identifier: 00884389102551
• UDI-Public: 00884389102551
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• 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: 09/05/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown