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	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1ea of their (b)(6) glucometers is reading low control solution out of range of what is printed on the strip bottle.I asked customer to try again while on the phone and it read 33 while the test strip bottle states 39-69.
Additional Manufacturer Narrative
The customer reported a glucometer was reading low control solution out of range of what is printed on the strip bottle, and no medical intervention, serious injury, or follow-up care has been reported.A sample(s) was not received for investigation; investigation included review of recent complaint trends/scar activity for the last three trend reports, and per vendor, through internal investigation including dhr review and inspection records review, no abnormalities were found.The investigation results were unconfirmed, and 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; the recorded cause was sample required to determine cause.No trends were identified for the specified material number and its corresponding defect type, and division will continue to monitor trends.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: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868675
• Report Number: 1417592-2026-48734
• Device Sequence Number: 16131345
• Product Code: CGA
• UDI-Device Identifier: 10884389831199
• UDI-Public: 10884389831199
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• 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: 12/05/2025
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown