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

Catalog Number	MPH6540
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "product is not working and will not calibrate.".
Additional Manufacturer Narrative
The reported failure was that the product is not working and will not calibrate.Medline received one harmony blood glucose meter in used condition; the sample came with 2 working batteries, test strips and control solutions used by the customer were not sent for investigation, and the sample was tested according to the instructions for use with two tests, one for each control solution.Control solution results were 47 mg/dl for level 1 and 222 mg/dl for level 3, respectively, and no issues were seen during testing; the sample turned on/off as intended, the test strip ejector worked properly, and readings were within control solution range.The complaint was not confirmed, the cause was not confirmed with received sample, and the sample worked as intended.There were no reports of death, serious injury, medical intervention, or follow up care.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: METER, GLUCOSE, HARMONY,PROF.USE ONLY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50944883
• Report Number: 1417592-2026-54014
• Device Sequence Number: 10451556
• Product Code: LFR
• UDI-Device Identifier: 10888277675674
• UDI-Public: 10888277675674
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 11/20/2023
• 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: 11/09/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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