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

Catalog Number	MPH1545
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when the customer inserts a test strip into the meter the strip continues to flash at the bottom of the screen.Customer has tried different strips but could not reslove issue.".
Additional Manufacturer Narrative
The customer reported that when a test strip was inserted into the meter, the strip continued to flash at the bottom of the screen, and different strips did not resolve the issue.The investigation states the customer called in and stated that they were able to get the monitor working again, requested closure, and advised that they will be keeping their product with no need for a replacement or a credit.No examination or testing results were documented; therefore, the reported problem could not be evaluated or confirmed.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: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886618
• Report Number: 1417592-2026-50352
• Device Sequence Number: 15909429
• 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): 09/24/2026

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: MPH1545
• 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: 01/19/2024
• Initial Report FDA Received Date: 09/24/2026
• 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