MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CONTROL,EVENCARE G2 HI LO

Catalog Number	MPH1560Z
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "her evencare g2 meter was reading out of range when she tested the control solutions." it was reported that "both the high and low read out of range.".
Additional Manufacturer Narrative
The customer reported receiving medline glucose meter control solutions that experienced inaccurate reading; the end-user confirmed that everything was within the listed expiration date, including strips and control solutions, and she was following the correct procedure when testing the control solutions.There was no reported death or serious injury associated with this event.At this time, the sample was not received for investigation after multiple good faith attempts, and the lot number was also requested but no response was provided.The complaint was not confirmed, and without the sample and lot number is difficult to determine the root cause of the issue; the division will continue to monitor trends, and no trends were identified for the specified material number and its corresponding defect type.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: CONTROL,EVENCARE G2 HI LO
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50948416
• Report Number: 1417592-2026-54602
• Device Sequence Number: 13369389
• Product Code: JJX
• UDI-Device Identifier: 00884389102544
• UDI-Public: 00884389102544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090043
• 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): 09/29/2026

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: MPH1560Z
• 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: 04/02/2025
• Initial Report FDA Received Date: 09/30/2026
• 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: Female