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
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded the expected negative results.Retained devices were also tested with qc cut-off positive standards.The results were read at 3 minutes and all devices yielded the expected positive results.No false results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformance's and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retained product.Complaints are tracked and trended on a monthly basis.Per the package insert: false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine or serum specimen should be collected 48 hours later and tested.This test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.
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
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 24263204
• Report Number: 2027969-2026-00024
• Device Sequence Number: 13269716
• 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
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White