MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STRIP,TEST,GLUCOSE,HARMONY

Catalog Number	MPH6550
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	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they are all out of the control range.".
Additional Manufacturer Narrative
A complaint was received, and the customer reported the strips, monitors, and control solutions were "out of control range"; there was no reported death or serious injury, and the customer did not state when the event occurred.Medline received glucose monitors, glucose test strips, and control solutions; visual inspection of the opened monitors found no cosmetic damage, and functional testing with new batteries and controlled solution testing produced values within acceptable ranges.The complaint was not confirmed.No root cause was identified, and no further action was taken because objectionable trends were not seen for this issue.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: STRIP,TEST,GLUCOSE,HARMONY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50871490
• Report Number: 1417592-2026-49177
• Device Sequence Number: 10715202
• Product Code: NBW
• UDI-Device Identifier: 10888277675681
• UDI-Public: 10888277675681
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/23/2026

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: MPH6550
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2026
• 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: 03/05/2026
• Initial Report FDA Received Date: 09/23/2026
• 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: Unknown