MAUDE Adverse Event Report: SEKISUI DIAGNOSTICS, LLC OSOM HCG URINE TEST; HCG URINE PREGNANCY TEST KIT

Model Number	101
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient's first morning urine was tested with an osom hcg urine test, and the result was negative.No serum quantitative hcg was performed.On the same day, the patient had an abdominal surgical procedure.A mass was discovered during the procedure which turned out to be a third trimester pregnancy.The surgery was halted, and the patient was admitted to hospital.Additional details of the event (such as which procedure the patient had, patient weight, etc.) were not provided.Details regarding the outcome of the patient or the pregnancy were also not provided.The customer stated they had been using the same lot for some time, and that they are a high-volume facility (approx.50 hcg per day).The facility reported no other false negatives had been obtained using this lot.
Additional Manufacturer Narrative
The test kit is not going to be returned for investigation.The user guide for the osom hcg urine test recommends that positive and negative external controls be run with each new lot and with each new untrained operator.The customer indicated that they did not perform control testing on this lot prior to use.A retain kit for osom hcg urine test (part number 101) lot number 241012 was tested and performed within test and control line release specifications for controls tested.The negative control produced a negative result and the positive control produced a positive result.Sekisui did not find any performance deficiencies with the osom hcg urine test.The definitive cause of the noted false negative result described within this report is unknown.However, as summarized in the limitations in the ifu, the assay is capable of detecting only whole molecule (intact) hcg but cannot detect hcg fragments.Later term pregnancies beyond the first trimester may contain high levels of hcg fragments.Therefore, the osom hcg urine test is most effective when used for the detection of pregnancy in its earlier stages.

• Brand Name: OSOM HCG URINE TEST
• Common Device Name: HCG URINE PREGNANCY TEST KIT
• Manufacturer (Section D): SEKISUI DIAGNOSTICS, LLC; 6659 top gun street; san diego CA 92121
• Manufacturer (Section G): SEKISUI DIAGNOSTICS, LLC; one wall street; burlington MA 01803
• Manufacturer Contact: rob ; one wall street; burlington, MA 01803
• MDR Report Key: 21107248
• Report Number: 2030538-2025-00001
• Device Sequence Number: 12925842
• Product Code: JHI
• UDI-Device Identifier: 00742860001017
• UDI-Public: 00742860001017
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K974159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 101
• Device Lot Number: 241012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/08/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 35 YR
• Patient Sex: Female