MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG PREGNANCY TEST CASSETTE (URINE); VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: was selected as 1may2025.The specific date was not provided; however the customer indicated the events took place the second/third week of may in 2025.Results pending completion of the investigation.
Event or Problem Description
The customer reported receiving faint false positive hcg results while using four boxes of medline hcg pregnancy test cassettes.The customer reported testing patient urine samples with medline hcg test cassettes during the second/third week of may in 2025.It was reported that faint positive results were obtained, and the control lines would appear at 3-5 minutes.Additionally, the "background was never fully clear (white), so control line was hard to see, or an incomplete line would appear along with a positive line." the number of false positive results or patients involved was not provided.However, the customer indicated 3-4 hcg tests had to be used to confirm the results.Some of the faint positive results were obtained on patients who were not pregnant.Confirmatory hcg quantitative testing was ordered in some instances which resulted negative.Although requested, no further information was provided.No adverse health outcomes were reported.Please note the following from the package insert: wait for the red lines(s) to appear.Read the results at 3-4 minutes.Do not interpret results after the appropriate read time.Positive: two distinct red lines appear.It is important that the background is clear before the result is read.
Additional Manufacturer Narrative
B3 - date of event: was selected as 1may2025.The specific date was not provided; however the customer indicated the events took place the second/third week of may in 2025.D4 - primary udi number: was updated to include the udi.D9 - date returned to mfg: was updated to 8/29/2025.H3 - device evaluated by mfg?, h6 - adverse event problem, and h6 - adverse event problem: were updated to include return and retain testing.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine and 25 miu/ml cut-off hcg urine samples.The results were read at 3 and 4 minutes for devices tested with negative samples and all devices yielded negative results.The results were read at 3 minutes for devices tested with positive samples and all devices yielded positive results.Returned devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded negative results with strong solid control lines.No false results, unclear background issues, slow results or control line issues 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-conformances 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: - very low levels of hcg (less than 50 miu/ml) are present in urine specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.- a number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.- 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.- wait for the red line(s) to appear.Read the result at 3-4 minutes.Do not interpret results after the appropriate read time.It is important that the background is clear before the result is read.
Event or Problem Description
The customer reported receiving faint false positive hcg results while using four boxes of medline hcg pregnancy test cassettes.The customer reported testing patient urine samples with medline hcg test cassettes during the second/third week of (b)(6) in 2025.It was reported that faint positive results were obtained, and the control lines would appear at 3-5 minutes.Additionally, the "background was never fully clear (white), so control line was hard to see, or an incomplete line would appear along with a positive line." the number of false positive results or patients involved was not provided.However, the customer indicated 3-4 hcg tests had to be used to confirm the results.Some of the faint positive results were obtained on patients who were not pregnant.Confirmatory hcg quantitative testing was ordered in some instances which resulted negative.Although requested, no further information was provided.No adverse health outcomes were reported.Please note the following from the package insert: - wait for the red lines(s) to appear.Read the results at 3-4 minutes.Do not interpret results after the appropriate read time.- positive: two distinct red lines appear.- it is important that the background is clear before the result is read.

• Brand Name: MEDLINE HCG PREGNANCY TEST CASSETTE (URINE)
• 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: 22759554
• Report Number: 2027969-2025-00176
• Device Sequence Number: 9400480
• Product Code: JHI
• UDI-Device Identifier: 30888277191871
• UDI-Public: (01)30888277191871(17)261008(10)0000922000
• 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,Followup
• Report Date (Section B): 11/18/2025

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: 0000922000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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