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

Model 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	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they opened a new box of solutions and is not reading within range.".
Additional Manufacturer Narrative
The customer reported that they opened a new box of solutions and it was not reading within range.Medline received one evencare g2 low control solutions in used condition and ran a control test using both high and low solutions; the results were 57 mg/dl for the low control test and 218 mg/dl for the high control test, which fall within the correct range for the low control and the high control.The complaint was not confirmed.The issue reported was likely caused by improper storage of test strips that led to contamination of the strips; the sample functioned as intended, and 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: CONTROL,EVENCARE G2 HI LO
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50922955
• Report Number: 1417592-2026-52555
• Device Sequence Number: 5753355
• Product Code: NBW
• UDI-Device Identifier: 00884389102544
• UDI-Public: 00884389102544
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2026

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 Model Number: MPH1560Z
• Device Lot Number: 16822013101/202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2023
• 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: 11/20/2023
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown