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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact on (b)(6) 2026, there was a "false positive urine hcg test." the customer reported a "quantitative serum hcg test was performed to confirm the results." per the customer contact, the test was ordered as part of a post-partum follow-up visit and prior to iud placement.The customer contact reported as a result of the reported incident, "the procedure was delayed" and "the patient had to return in 1 week for repeat testing." the customer contact stated the patient returned on (b)(6) 2026 and completed the intended procedure.The customer did not report any serious injury related to the reported incident.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Event or Problem Description
According to the customer contact on (b)(6) 2026, there was a "false positive urine hcg test." the customer reported a "quantitative serum hcg test was performed to confirm the results.".
Additional Manufacturer Narrative
Updated b1: adverse event or product problem.Updated h1: type of report.

• 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 2753
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24830110
• Report Number: 1417592-2026-00397
• Device Sequence Number: 21137737
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MPH22025HCG
• Device Lot Number: 0001133757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic