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	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported receiving several false positive results while using the consult hcg urine tests on four different patients.On (b)(6) 2024, the customer indicated one patient received false positive hcg results on that day and three patients received false positive results one month prior.It was reported that all patients had confirmatory testing performed which yielded negative hcg results.The customer indicated the most recent patient from (b)(6) 2024 provided a fresh urine sample, the results were read at 5 minutes and 3 positive hcg results were observed.Technical services advised per the package insert, read the result at 3-4 minutes.Do not interpret results after the appropriate read time.No adverse events were reported, therefore this event is not considered reportable.It is currently unclear if this read time deviation applies to the 3 patients from the month prior, therefore 3 mdrs will be conservatively filed.See mdr 2027969-2025-00008 and 2027969-2025-00010 regarding the false positive results from patient 1 and 3 respectively.
Additional Manufacturer Narrative
B3 - date of event: was not provided.The customer indicated in (b)(6) 2024 that the event occurred last month.Investigation conclusion: retained 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 valid negative results.No false positive 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-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.Case details indicate several of the tests results were read at 5 minutes.It is unclear if the results of all tests were read at 5 minutes.According to package insert, "read the result at 3-4 minutes.Do not interpret results after the appropriate read time." a definitive root cause could not be determined from the available information as the reported issue was not replicated during retention testing and it is not clear if the observed deviation occurred every time.Complaints are tracked and trended on a monthly basis.Per the package insert: - note: a sample hcg concentration below the cut-off level of this test might result in a weak line appearing in the test region (t) after an extended period of time.A line in the test region (t) seen after the read time could be indicative of a low hcg level in the sample.If such results are seen, it is recommended that the test be repeated with a new sample in 48-72 hours or that an alternate confirmation method is used.- 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.

• 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: 21107675
• Report Number: 2027969-2025-00009
• Device Sequence Number: 20871314
• Product Code: JHI
• UDI-Device Identifier: 20612479202751
• UDI-Public: (01)20612479202751(17)260306(10)0000849013
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: 03/06/2026
• Device Model Number: FHC-101
• Device Catalogue Number: 5000
• Device Lot Number: 0000849013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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