MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU

Catalog Number	MPH22025HCG
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have now come across 2 boxes of medline branded pregnancy tests that have given us false positives on now 4 patients.We had instances where we told the patient they were pregnant and they were not.".
Additional Manufacturer Narrative
The customer reported medline pregnancy tests were giving false positives, and stated, "we had instances where we told the patient they were pregnant and they were not"; the customer later stated the tests had given false positives on 5 patients, patients were upset, and no serious injury, medical intervention, or follow-up care was required.A sample was not received for investigation, and retained devices from the reported lot numbers were tested with hcg-negative clinical urine and hcg-negative clinical serum samples; all devices yielded valid negative results and no false positive results were observed during in-house testing.The complaint was not confirmed, and manufacturing batch record review did not uncover any relevant non-conformances and found that the lots met quality control specifications.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product, and no indications of a systemic issue were 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,HCG,PREGNANCY,COMBO,CASS,20/10 MIU
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947015
• Report Number: 1417592-2026-54372
• Device Sequence Number: 9499641
• Product Code: JHI
• UDI-Device Identifier: 10884389191880
• UDI-Public: 10884389191880
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• 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): 09/23/2026

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: MPH22025HCG
• Device Lot Number: 0000967206
• 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: 11/03/2025
• Initial Report FDA Received Date: 09/30/2026
• 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