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

Catalog Number	MPH6550Z
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "issues with blood glucose strips not reading correctly".
Additional Manufacturer Narrative
The customer reported issues with blood glucose strips not reading correctly; according to the facility the device "would sometimes lag and not get out of control mode" which would cause a delay in getting a reading and would at times "shut off after being turned on." medline received 2 samples, tested the meter using control blood glucose test strips and harmony glucose control solutions following the instructions for use, and completed four tests, two tests for each control solution.The complaint was not confirmed; during testing one of the meters turned on/off as normal, no warning or other error signs were displayed, and control solution readings were within range, while the other sample was visibly damaged as if it had been dropped and the middle of the screen would not display making it impossible to test and record readings.Investigation results were customer caused, the cause code was updated to reflect misuse/mishandling, and there are currently no known trends for this product lot and 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: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50949548
• Report Number: 1417592-2026-54744
• Device Sequence Number: 9534366
• Product Code: NBW
• UDI-Device Identifier: 20888277675688
• UDI-Public: 20888277675688
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: MPH6550Z
• Device Lot Number: 16823114001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2024
• 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: 05/13/2024
• 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): 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