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

Catalog Number	MPH50025M
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when we ran the controls, the tests did not react to the positive control giving us a false negative result.We tried a couple of different tests and also tried the controls from the previous box and still had the same false negative results.".
Additional Manufacturer Narrative
The customer reported that, when the controls were run, the tests did not react to the positive control giving a false negative result, and a couple of different tests and the controls from the previous box still had the same false negative results.The vendor was notified of the customer's concern, the completed lifesign form was sent to the vendor, and the vendor responded that they had reached out to the customer and were waiting for a response; the record states that the investigation will be done by the vendor or vendor affiliates.The record does not document confirmation of the reported problem or an identified root cause; no additional investigation is required.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: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883858
• Report Number: 1417592-2026-49892
• Device Sequence Number: 21521189
• Product Code: KTN
• UDI-Device Identifier: 30888277191895
• UDI-Public: 30888277191895
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/23/2026

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: 222D11
• 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: 09/25/2023
• Initial Report FDA Received Date: 09/24/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown