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

Catalog Number	MPH1560
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that these controls are not giving accurate readings.The low solutions are giving readings that are way too low and inaccurate.
Additional Manufacturer Narrative
The customer reported receiving a medline glucose control solution that has low readings and stated that the low solutions are giving readings that are way too low and inaccurate.Medline received 6ea mph1560 evencare g2 blood glucose control solutions and tested them with test strips and a control glucose meter; additional samples of glucose strips and control solutions were later received and tested with the provided control solution.The complaint was not confirmed, and both additional tests passed.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: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872055
• Report Number: 1417592-2026-49237
• Device Sequence Number: 18820416
• Product Code: JJX
• UDI-Device Identifier: 00884389102544
• UDI-Public: 00884389102544
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/23/2026

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: MPH1560
• Device Lot Number: 16824043102/202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2025
• 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: 02/18/2025
• Initial Report FDA Received Date: 09/23/2026
• 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