MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST,HCG,PREGNANCY,URINE,CASS, 25 MIU

Catalog Number	MPH12025HCG
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when administering test to patient the test show faintly positive for two tests in a row.".
Additional Manufacturer Narrative
According to the facility, the test showed faintly positive for two tests in a row, and the patient scheduled to have an iud inserted had a positive pregnancy test; the doctor had the blood drawn and sent to stat pregnancy and it came back negative, and the doctor repeated the test with the tester from a different box and it came back negative.At this time, a sample was not received for investigation; investigation included review of recent complaint trends/scar activity for the last three trend reports, and no trends were identified.The complaint was not confirmed, and per vendor, through internal investigation no abnormalities were found and the complaint could not be confirmed.Based on the available information and vendor findings, the reported issue could not be confirmed, therefore a root cause could not be determined, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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,HCG,PREGNANCY,URINE,CASS, 25 MIU
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856721
• Report Number: 1417592-2026-47935
• Device Sequence Number: 9652063
• Product Code: JHI
• UDI-Device Identifier: 10888277191877
• UDI-Public: 10888277191877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• 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: MPH12025HCG
• Device Lot Number: 0000667262
• 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: 10/20/2023
• Initial Report FDA Received Date: 09/22/2026
• 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