MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST, DRUG, 12 PANEL, A.D, 25/BX

Catalog Number	MPHD122A3C
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "drug testing cup mphd122a3c, lot w512505016 cups will produce a negative result for suboxone showing a faint line, and we verified with a different drug test that the test should be positive and there should be no line visisble.".
Additional Manufacturer Narrative
The customer reported that the drug testing cup would produce a negative result for suboxone showing a faint line, and they verified with a different drug test that the test should be positive and there should be no line visible.Medline received 2 drug test cups; due to the nature of this complaint (false negative), medline was not able to test in house, reached out to the vendor, and the vendor conducted internal investigation including dhr review, inspection records review, and retention sampling testing on this batch of products.The complaint record contains conflicting confirmation statements, including "complaint was (not) confirmed" and "the complaint was confirmed," while the cause section lists "not confirmed with received sample"; the vendor found no abnormalities, and bup positive control tested against three retained samples produced correct positive results.No root cause was identified; possible reasons for the false negative bup result included testing outside the detection window period or product storage/test environment not according to product specifications, and the division will continue to monitor trends.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, DRUG, 12 PANEL, A.D, 25/BX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL
• MDR Report Key: 50773577
• Report Number: 1417592-2026-40600
• Device Sequence Number: 13396367
• Product Code: NFT
• UDI-Device Identifier: 10193489017540
• UDI-Public: 10193489017540
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K182701
• 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): 09/10/2026

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: MPHD122A3C
• Device Lot Number: W512505016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/29/2025
• 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: 12/16/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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