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

Catalog Number	MPH50025M
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have two patients that have tested positive on the medline kit and negative on the osom kit.We reran the patients on both kits again and still have medline showing as positive and osom showing as negative.".
Additional Manufacturer Narrative
The customer reported discrepancies in the test performance for mono kits (medline and osom); during comparison studies, two of the patients tested positive with the medline kit but not with the osom kit, and the product was used according to the package insert.At this time, a sample(s) was not received for investigation but one was sent to the vendor; investigation included review of recent complaint trends, and per vendor, through internal investigation no abnormalities were found.The complaint was not confirmed and no root cause was identified.No further action was taken because objectionable trends were not seen, and the division will continue to monitor the issue for trending.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: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931059
• Report Number: 1417592-2026-52854
• Device Sequence Number: 21223360
• Product Code: KTN
• UDI-Device Identifier: 30888277191895
• UDI-Public: 30888277191895
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/27/2026

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: 223E11
• 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: 02/27/2024
• Initial Report FDA Received Date: 09/29/2026
• 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