MAUDE Adverse Event Report: Alere San Diego, Inc. MEDLINE hCG Pregnancy Test Cassette; Visual, Pregnancy Hcg, Prescription Use

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that a customer received two false negative hcg results while using medline hcg pregnancy test cassettes.The patient presented after receiving a positive home urine pregnancy hcg test.The patient's urine was tested in office which yielded 2 negative hcg results.A confirmatory hcg blood test was performed which yielded a positive hcg test.The customer reported quality control testing was performed which also yielded a false negative hcg result.No adverse health outcomes were reported.As a result of the negative test result, the patient now undergoes serial hcg lab work weekly.
Additional Manufacturer Narrative
B3 - date of event: was not provided, therefore (b)(6) 2026 was selected.Preliminary investigation findings (pending return testing): an investigation was performed on retention product from the reported lot number.Retention devices were tested with high positive standards (204.75iu/ml and 232.43iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negatives 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 abnormalities 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 retention product.Complaints are tracked and trended on a monthly basis.Per the package insert: 1.Place the test cassette on a clean and level surface.Hold the pipette vertically and transfer 3 full drops of urine (approx.100 l) to the specimen well (s) of the test cassette, and then start the timer.Avoid trapping air bubbles in the specimen well (s).Wait for the red line(s) to appear.Read the result at 3¿4 minutes.2.Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.3.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 serum or urine specimen should be collected 48 hours later and tested.4.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.5.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: MEDLINE hCG Pregnancy Test Cassette
• 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 ; +1(858)805-2506
• MDR Report Key: 25131220
• Report Number: 2027969-2026-00048
• Device Sequence Number: 15784541
• Product Code: JHI
• UDI-Device Identifier: 10888277191877
• UDI-Public: (01)10888277191877(17)270721(10)0001155711
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: k993317
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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 Model Number: FHC-102
• Device Catalogue Number: MPH12025HCG
• Device Lot Number: 0001155711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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 Sex: Female