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	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was showing false negative result.
Additional Manufacturer Narrative
It was reported that "we ordered 16 boxes of these at the end of july.We use these mainly for the bup.There were at least 5 in one day that came back negative for this drug.We had to send these out to our lab for confirmation, which did come back positive for the drug.This occurred several days.Drug cups are no longer used due to false negative results."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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• 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: muniba anwar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50927508
• Report Number: 1417592-2026-10471
• Device Sequence Number: 13451626
• Product Code: NFT
• UDI-Device Identifier: 10193489017540
• UDI-Public: 10193489017540
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MPHD122A3C
• Device Lot Number: W512509017
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Race: White