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	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there have been issues with the positive control not showing positive." it was also reported that "the positive test line is often very faint and we had a couple of true positives that came up negative on the new kit.".
Additional Manufacturer Narrative
The complaint was received for a mono test kit in which the customer reported multiple quality control tests produced negative results when expected positive control testing was performed.The customer repeated testing using the kit-supplied pipette, a calibrated laboratory pipette, and an additional kit, with the same reported outcome.No patient testing was affected, and no adverse health consequences were reported.No sample, photographs, or additional product evidence were returned for evaluation.Additional information was requested but was not provided.Based on the information available, medline was unable to confirm the complaint issue or determine whether the product failed to meet specifications.The cause was documented as ¿unconfirmed defect - sample required to determine cause.¿ a review of the complaint information and available investigation results indicated no need for further action, and complaints are monitored through the trend analysis process.There were no reports of death, serious injury, medical intervention, follow-up care, or patient impact associated with this event.It has been determined that the reported event could cause or contribute to a serious injury if it were to recur.In an abundance of caution, this is a reportable event.If additional information becomes available, this complaint will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities conducted in accordance with 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: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50616202
• Report Number: 1417592-2026-32646
• Device Sequence Number: 13436137
• Product Code: KTN
• UDI-Device Identifier: 30888277191895
• UDI-Public: 30888277191895
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/02/2026

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: 223E11
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• 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