MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SURE-VUE¿ SERUM/URINE HCG-STAT; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-A202
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported false results while using the sure-vue¿ serum/urine hcg-stat devices.Although requested, no further information was provided.No adverse health outcomes were reported.
Additional Manufacturer Narrative
B3 - date of event: was not provided, therefore (b)(6) 2025 was selected.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine and hcg-negative clinical serum samples.The results were read at 3 and 4 minutes for devices tested with urine and 5 and 6 minutes for devices tested with serum.Additionally, retained devices from the reported lot number were tested with hcg cut-off (20miu/ml) urine and hcg cut-off (10miu/ml) serum samples.The results were read at 3 minutes for devices tested with urine and 5 minutes for devices tested with serum.All devices yielded tested with hcg-negative samples yielded negative results and all devices tested with cut-off urine and cut-off serum samples yielded 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-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 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.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.Very low levels of hcg (less than 50miu/ml) are present in urine and serum 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 serum or urine specimen collected 48 hours later.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.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 serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.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.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: SURE-VUE¿ SERUM/URINE HCG-STAT
• 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: 23698819
• Report Number: 2027969-2025-00239
• Device Sequence Number: 10288402
• Product Code: JHI
• UDI-Device Identifier: 00613647000533
• UDI-Public: (01)00613647000533(17)270112(10)0000958539
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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-A202
• Device Catalogue Number: 23900531
• Device Lot Number: 0000958539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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