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

Catalog Number	MPH6540
Medical Device Problem Codes	High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "today they went to qc a new bottle of strips and the low control is reading high and high reading low.".
Additional Manufacturer Narrative
It was reported that during qc of a new bottle of strips, "the low control is reading high and high reading low," and it "was done multiple times by 2 different staff members." medline received the harmony blood glucose meter in used condition; the glucose control solutions and test strips used by the account were not provided, and medline tested the sample using harmony glucose control solutions and harmony blood glucose test strips, with level 1 and level 3 results of 47 mg/dl and 211 mg/dl, respectively, within test ranges.The complaint was not confirmed, and the cause code was not confirmed with received sample.Medline saw no issues during testing, the sample turned on as intended, readings were within the control solutions range, and the sample worked as intended.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: METER, GLUCOSE, HARMONY,PROF.USE ONLY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946544
• Report Number: 1417592-2026-54285
• Device Sequence Number: 21419616
• Product Code: LFR
• UDI-Device Identifier: 10888277675674
• UDI-Public: 10888277675674
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 03/03/2025
• 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: 02/20/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown