MAUDE Adverse Event Report: PRINCETON BIOMEDITECH CORPORATION OSOM ULTRA HCG COMBO TEST; PREGNANCY TEST

Catalog Number	1004
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned serum sample from patient 2 provides evidence that the discrepancy is not a product defect, but rather a result of endogenous biological interference, commonly referred to as "phantom hcg".The clinical profiles of the involved patients suggest multiple pathways for assay interference.This malfunction compromises the device's diagnostic effectiveness, but it is not likely to contribute to death or serious injury.
Event or Problem Description
Three patient serum samples yielded false-positive results on the osom ultra hcg combo test, while subsequent quantitative laboratory testing confirmed that all three patients were hcg-negative.Additional patient information: patient #2, patient identifier - confidential patient age: 14 year(s).Patient weight: 81 kg.Date of event: (b)(6) 2025.Patient #3, patient identifier - confidential.Patient age: 16 year(s).Patient weight: 65 kg.Date of event: (b)(6) 2025.

• Brand Name: OSOM ULTRA HCG COMBO TEST
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): PRINCETON BIOMEDITECH CORPORATION; 4242 us highway 1; monmouth junction NJ 08852 1905
• Manufacturer (Section G): PRINCETON BIOMEDITECH CORPORATION; 4242 us highway 1; monmouth junction NJ 08852 1905
• Manufacturer Contact: young-a kim ; 4242 us highway 1; monmouth junction, NJ 08852-1905 ; 7322741000
• MDR Report Key: 24048386
• Report Number: 2246703-2026-00001
• Device Sequence Number: 10023309
• Product Code: JHI
• UDI-Device Identifier: 00742860100208
• UDI-Public: 00742860100208
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K944426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 1004
• Device Lot Number: 565E13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 66 KG