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

Catalog Number	MPH1560Z
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "lot # 16822092102/202 is reading low.Test ran and came back at 50 and the bottle of strips perameteres are 53-79.".
Additional Manufacturer Narrative
The customer reported the control was reading low; the test ran and came back at 50 and the bottle of strips parameters are 53-79, while the customer tested high solution from the same lot and read correctly.Complaint could not be confirmed as there were no samples or pictures received.Without a sample received it is difficult to determine a true root cause for the reported issue.The division performs quarterly trending on all complaints received, and should the sample/detailed picture become available, the complaint will be reopened and investigated accordingly.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: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898056
• Report Number: 1417592-2026-50953
• Device Sequence Number: 6026549
• Product Code: JJX
• UDI-Device Identifier: 00884389102544
• UDI-Public: 00884389102544
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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: 11/07/2023
• Initial Report FDA Received Date: 09/25/2026
• 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