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

Catalog Number	MPH1540
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when she inserts a test strip, it gives her error code e3 each time.She also stated when she received the meter the date and time was already setup on the meter." it was also reported that "per customer, she is having the same issue with the replacement monitor.".
Additional Manufacturer Narrative
The customer stated she received the g2 meter and when she inserts a test strip, it gives her error code e3 each time, and the date and time was already setup on the meter; per customer, she is having the same issue with the replacement monitor.Medline received 2 ea blood glucose meters; functional testing was performed using test strips on site as well as control solution with ranges 45-75 for low, and 176-238 for high, and results showed 61/220 and 61/210 reading within range.An error code was not encountered for the duration the device was in testing, and the complaint was not confirmed.Investigation included review of recent complaint trends, objectionable trends were not seen for this issue, and based on the review of the details provided for the complaint investigation, 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: METER, GLUCOSE, EVENCARE G2
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947445
• Report Number: 1417592-2026-54446
• Device Sequence Number: 9552482
• Product Code: NBW
• UDI-Device Identifier: 00884389102551
• UDI-Public: 00884389102551
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/22/2026

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: 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: 03/27/2023
• Initial Report FDA Received Date: 09/30/2026
• 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: Female