MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-CED-TEST,HCG,PREGNANCY,COMBO,CASS,20

Catalog Number	MPH22325HCG
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported receiving medline standard hcg pregnancy tests that had a "false positve test," and multiple false positive pregnancy test results were reported across sutter sites using the medline hcg test kit.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 the vendor tested the hcg test with different negative serum and negative urine samples within the specified reading time.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 corresponding defect type, all vendor results met qc criterion, and the division will continue to monitor trends.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 false positive pregnancy test results have been reported across sutter sites using medline hcg test kit.".

• Brand Name: MEDLINE
• Common Device Name: DBQ-CED-TEST,HCG,PREGNANCY,COMBO,CASS,20
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50720842
• Report Number: 1417592-2026-36386
• Device Sequence Number: 8542719
• Product Code: JHI
• UDI-Device Identifier: 10197344024995
• UDI-Public: 10197344024995
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203272
• 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): 09/10/2026

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: MPH22325HCG
• Device Lot Number: 75425010001
• 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: 05/23/2025
• Initial Report FDA Received Date: 09/10/2026
• 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