MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STARTER KIT, GLUCOSE, EVENCARE G2 1EA

Catalog Number	MPH1545
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "item #mph1545,starter kit, glucose, evencare g2 1ea does not work, item does not reconize the test strip that came included in the kit, mb stated he calibrated the machine and it does not work, he stated he try using multiple test strips and is not reading the test strips.".
Additional Manufacturer Narrative
It was reported that the evencare g2 glucose starter kit that was not recognizing the test strips; the item does not recognize the test strip that came included in the kit, the customer stated he calibrated the machine and it does not work, and he tried using multiple test strips and it is not reading the test strips.Medline received 1ea evencare g2 blood glucose meter starter kit in like-new condition, inserted 2 aa control batteries, and tested the sample using evencare g2 glucose control solutions and the evencare g2 blood glucose test strips that the customer provided with the sample.Automatically, the meter turned on and the blood icon appeared on the screen indicating the unit was ready for testing; control solution results were 56 and 192 mg/dl, respectively, and they were within test ranges of 40-70 and 170-230 mg/dl; the issue reported may have been caused due to placing the strips inside the meter upside down, and the sample worked as intended.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: STARTER KIT, GLUCOSE, EVENCARE G2 1EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL
• MDR Report Key: 50838919
• Report Number: 1417592-2026-45931
• Device Sequence Number: 10059963
• Product Code: NBW
• UDI-Device Identifier: 00884389102407
• UDI-Public: 00884389102407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102037
• 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): 09/18/2026

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: MPH1545
• Device Lot Number: 16824122016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2025
• 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: 08/25/2025
• Initial Report FDA Received Date: 09/21/2026
• 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: Male