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	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "lancing device is not properly wokring to allow the lancet to pucture the skin.".
Additional Manufacturer Narrative
The complaint description was "lancet will not punture skin," and the complaint transcript stated the lancing device was not properly working to allow the lancet to puncture the skin.Medline requested the product be shipped back, provided a fedex call tag, and requested photos and/or the return of the product; however, there were no samples or pictures received.The complaint could not be confirmed and medline was unable to confirm the complaint issue or that the product failed to meet specifications; without a sample received it is difficult to determine a true root cause for the reported issue.Complaints are monitored via the trend analysis procedure, and review of the last three trend reports found no trends for the specified material number and its corresponding defect type; if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50801152
• Report Number: 1417592-2026-43195
• Device Sequence Number: 8644163
• Product Code: NBW
• UDI-Device Identifier: 00884389102407
• UDI-Public: 00884389102407
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/16/2026

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: 04/10/2023
• Initial Report FDA Received Date: 09/17/2026
• 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