MAUDE Adverse Event Report: Medline Industries, LP Medline; METER, GLUCOSE, HARMONY,PROF.USE ONLY

Catalog Number	MPH6540
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: METER, GLUCOSE, HARMONY,PROF.USE ONLY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield, IL 60093 -275
• Manufacturer Contact: muniba anwar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50941446
• Report Number: 1417592-2026-53966
• Device Sequence Number: 10739904
• Product Code: NBW
• UDI-Device Identifier: 10888277675674
• UDI-Public: 10888277675674
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161299
• 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): 09/29/2026

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: MPH6540
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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