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

Catalog Number	MPH50025M
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "testing the test kit and both the positive and the negative showed up as negative.".
Additional Manufacturer Narrative
The customer reported receiving a medline mono test cassette that had "negative results," and according to the facility, both qcs tested negative; no patients were involved.No sample was received but a photo was sent in, recent complaint trends/scar activity for the last three trend reports were reviewed, and the vendor tested three retained devices with the positive control.Based on the vendor investigation, the complaint was not confirmed.The most probable cause was improper test performance, and when the test instructions were followed, the positive control contained in the mono kit box worked properly.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: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867549
• Report Number: 1417592-2026-48597
• Device Sequence Number: 9224008
• Product Code: KTN
• UDI-Device Identifier: 10888277191891
• UDI-Public: 10888277191891
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/22/2026

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: 224A11A
• Was Device Available for Evaluation?: Yes
• 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: 07/29/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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