MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST,IFOBT,CASSETTES/TUBES

Catalog Number	MPH70025CT
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer is experiencing issues with the tests showing no control line.Tests from both boxes are having the same reaction, no control line".
Additional Manufacturer Narrative
The customer reported issues with the tests showing no control line, and tests from both boxes are having the same reaction, no control line.Investigation included review of recent complaint trends, and the vendor performed testing with 3 test devices and the positive control from the returned kit box; once migration started, distinct test lines formed within 3 minutes on all tested devices and lasted up to 15 minutes.No discrepant result was detected, the claim made by the customer was not repeated, and the complaint could not be confirmed.Through internal investigation, including dhr review and inspection records review, no abnormalities were found, and no root cause was identified.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,IFOBT,CASSETTES/TUBES
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856917
• Report Number: 1417592-2026-47974
• Device Sequence Number: 13245858
• Product Code: KHE
• UDI-Device Identifier: 30888277360017
• UDI-Public: 30888277360017
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K100817
• 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: MPH70025CT
• Device Lot Number: 763G11
• 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: 06/28/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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