MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST,MONO,CASS,25 TEST

Catalog Number	MPH50025M
Medical Device Problem Codes	Clumping in Device or Device Ingredient (1095); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1bx of tests are displaying 3 lines instead of 2.Control line, test line, and unknown middle line.
Additional Manufacturer Narrative
The customer reported 1bx of tests are displaying 3 lines instead of 2: control line, test line, and unknown middle line.The returned samples and customer-provided photo were reviewed, and three returned test devices were evaluated using the returned external positive control and compared against the customer's reported results.The investigation determined that the additional band observed below the control line was not a true test line, but rather an agglomeration of gold dye that may occur during sample migration; the customer-reported result could not be reproduced during testing, and the complaint was not confirmed.Based on the available evidence, the customer results were not verified, and no manufacturing defect was identified.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: TEST,MONO,CASS,25 TEST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896213
• Report Number: 1417592-2026-50705
• Device Sequence Number: 17642517
• Product Code: KTN
• UDI-Device Identifier: 30888277191895
• UDI-Public: 30888277191895
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K961024
• 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): 09/24/2026

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: MPH50025M
• Device Lot Number: 222G11
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2023
• 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: 04/27/2023
• Initial Report FDA Received Date: 09/25/2026
• 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