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

Catalog Number	MPH1545BT
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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the glucose monitor is not working properly and believes it is defective.The device is not reading accurately or giving accurate readings.
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving a medline glucose starter kit that has inaccurate readings.At this time, a sample(s) was not received for investigation; however, investigation included review of recent complaint trends for the last three trend reports and the vendor was notified.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo, and no trends were identified for the specified material number and its corresponding defect type.Cause was documented as sample required to determine cause; based on the review of the details provided for the complaint investigation, 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: STARTER KIT, GLUCOSE, EVENCARE G2 BT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50842615
• Report Number: 1417592-2026-46583
• Device Sequence Number: 10039783
• Product Code: NBW
• UDI-Device Identifier: 00197344007595
• UDI-Public: 00197344007595
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212140
• 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: MPH1545BT
• 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: 07/16/2025
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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