MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG DIPSTICK TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-101
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported receiving discrepant results for 2 different individuals when using consult hcg dipstick tests and consult hcg urine cassettes.The customer reported after receiving discrepant results for the first patient, the customer decided to test a colleague.The customer's colleague provided a fresh urine sample which yielded a faint positive hcg result with the dipstick test and a negative hcg result for the cassette test.The customer indicated they considered the faint positive hcg result to be false for the colleague.No adverse event was reported.No further information was provided.See mdr 2027969-2025-00057 for the discrepant result on patient 1.
Additional Manufacturer Narrative
Investigation conclusion: an investigation was performed on retention and return products from the reported lot number.Retention and returned devices were tested with clinical negative urine samples, cut-off standards (25 miu/ml), and high positive standards (201.1iu/ml, 204.6iu/ml, and 245.4iu/ml for retention testing and 201.1iu/ml and 223.3iu/ml for return testing).Results were read at 3 and 4 minutes for devices tested with negative samples.All devices tested with clinically negative urine samples yielded negative results.Results were read 3 minutes for devices tested with cut-off and high positive standard samples.All devices tested with cut-off and positive samples yielded positive results.No false positive or negative 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 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 or return 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.
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
The customer reported receiving discrepant results for 2 different individuals when using consult hcg dipstick tests and consult hcg urine cassettes.The customer reported after receiving discrepant results for the first patient, the customer decided to test a colleague.The customer's colleague provided a fresh urine sample which yielded a faint positive hcg result with the dipstick test and a negative hcg result for the cassette test.The customer indicated they considered the faint positive hcg result to be false for the colleague.No adverse event was reported.No further information was provided.See mdr 2027969-2025-00057 for the discrepant result on patient 1.

• Brand Name: CONSULT HCG DIPSTICK 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: 21527958
• Report Number: 2027969-2025-00058
• Device Sequence Number: 9619135
• Product Code: JHI
• UDI-Device Identifier: 20612479202751
• UDI-Public: (01)20612479202751(17)251203(10)0000818406
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K993203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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 Expiration Date: 12/03/2025
• Device Model Number: FHC-101
• Device Catalogue Number: 5000
• Device Lot Number: 0000818406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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 Age: 23 YR
• Patient Sex: Female