MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ONE STEP+ HCG COMBO TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Intermenstrual Bleeding (2665); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 14-jan-2026 the distributor reported conflicting results when testing a patient sample with the one step+ hcg combo test.The first test yielded a negative result at the read time of 3 minutes, with a faint line appearing after 15 minutes.The patient then underwent an iud insertion.A repeat test of the same sample yielded a clear positive result.A blood sample was collected and a quantitative hcg test was performed with a result of 32,022.9 (units not specified).An ultrasound was performed and a single live uterine pregnancy was detected with an estimated gestational age of 6 weeks and 3 days.Following the ultrasound, the iud was removed.An ultrasound was performed on (b)(6) 2026 due to cramping and bleeding.The ultrasound showed no complications; the pregnancy was determined to still be viable.No adverse outcomes have been reported as a result of the iud insertion, however this event is being reported as a serious injury due to the potential for miscarriage.

• Brand Name: ONE STEP+ HCG COMBO TEST
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• MDR Report Key: 24261944
• Report Number: 3006984151-2026-00001
• Device Sequence Number: 9550045
• Product Code: JHI
• UDI-Device Identifier: 10304040024123
• UDI-Public: (01)10304040024123(17)270518(10)0001008774
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026
• Report Date (Section F): 02/04/2026

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 Model Number: FHC-202
• Device Catalogue Number: 9004075
• Device Lot Number: 0001008774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/14/2026
• Date Report to Manufacturer: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White
• Date Report Sent to FDA: 02/04/2026