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

Catalog Number	MPH22025HCG
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "staff calling regarding false negative.".
Additional Manufacturer Narrative
The report states, "staff calling regarding false negative." customer reported, "nursing obtained a urine sample on a patient in the ed and ran the hcg combo pregnancy test and received a negative result.The patient subsequently received an abdominal x-ray where a pregnancy was discovered.Patient is fine." 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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• 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: sipara semu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913609
• Report Number: 1417592-2026-10427
• Device Sequence Number: 17485274
• Product Code: JHI
• UDI-Device Identifier: 10884389191880
• UDI-Public: 10884389191880
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MPH22025HCG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 303 LB
• Patient Race: White