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	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that urine hcg kit box, lot# hcg24080003u had 2 kits that tested positive.Serum hcg was sent out and resulted negative.
Additional Manufacturer Narrative
The customer reported receiving medline standard hcg pregnancy tests that had "false positives," and reported that 2 kits tested positive and serum hcg resulted negative.No sample; investigation included review of recent complaint trends/scar activity for the last three trend reports, and no trends were identified for the specified material and its defect type.The complaint was not confirmed.No further action was taken because without a sample/photo, it is difficult to identify the root cause; the division will continue to monitor trends.If the sample/photo/additional information is received at a later date, this report will be reopened, reevaluated, and this investigation will be reopened.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.This 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 reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• 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: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870107
• Report Number: 1417592-2026-49003
• Device Sequence Number: 18498160
• 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): 09/23/2026

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: MPH22325HCG
• Device Lot Number: HCO24080003U
• 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: 07/03/2025
• Initial Report FDA Received Date: 09/23/2026
• 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: Female