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

Catalog Number	MPHD122A3C
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the medline drug test cups were "not reading temperature" and stated, "we had a patient give us a sample and it showed no temperature, i poured that same urine in another cup and that one showed a temperature." at this time, a sample(s) was not received for investigation; investigation included review of recent complaint trends/scar activity for the last three trend reports, and per vendor, internal investigation including dhr review and inspection records review found no abnormalities.The complaint was not confirmed, and without the sample or picture, it is difficult to truly identify the root cause of the issue.No trends were identified for the specified material number and its corresponding defect type, the division will continue to monitor trends, and if the sample(s) is received at a later date, this investigation will be reopened.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.
Event or Problem Description
It was reported that "multiple cups did not temp" and "the cup read no temp".

• 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: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869569
• Report Number: 1417592-2026-48884
• Device Sequence Number: 18486796
• Product Code: NFT
• UDI-Device Identifier: 10193489017540
• UDI-Public: 10193489017540
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/22/2026

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: MPHD122A3C
• Device Lot Number: (10) W512502008
• 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: 06/25/2025
• 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): 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