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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported receiving false positive hcg results on an unspecified number of patients while using sure-vue¿ serum/urine hcg-stat tests.Technical services attempted to gather additional information; however the customer only responded indicating "the issue stemmed from the clinic not allowing the urine to come to room temperature.There were no issues with the kits." although requested, no further information was provided.No adverse health outcomes were reported.According to the package insert."allow the test device, serum or urine specimen and/or controls to equilibrate to room temperature (15-30°c) prior to testing." this event is conservatively being reported.
Additional Manufacturer Narrative
B3 - date of event: was not provided, therefore (b)(6) 2026 was selected.Results pending completion of the investigation.
Additional Manufacturer Narrative
B3 - date of event: was not provided, therefore 1jan2026 was selected.Investigation conclusion: 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 and retain device testing could not be performed as a lot number was not provided.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 indicated the customer reported the false positive issue was an isolated issue that stemmed from the clinic not allowing the urine come to room temperature.Please note: allow the test cassette, serum or urine specimen, and/or controls to equilibrate to room temperature (59-85°f / 15-30°c) prior testing.Although a deviation was noted, a definitive root cause could not be determined from the available information as a lot number was not provided.Complaints are tracked and trended on a monthly basis.Per the package insert: 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.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.
Event or Problem Description
The customer reported receiving false positive hcg results on an unspecified number of patients while using sure-vue¿ serum/urine hcg-stat tests.Technical services attempted to gather additional information; however the customer only responded indicating "the issue stemmed from the clinic not allowing the urine to come to room temperature.There were no issues with the kits." although requested, no further information was provided.No adverse health outcomes were reported.According to the package insert."allow the test device, serum or urine specimen and/or controls to equilibrate to room temperature (15-30°c) prior to testing." this event is conservatively being reported.

• 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: 24349825
• Report Number: 2027969-2026-00025
• Device Sequence Number: 10117830
• Product Code: JHI
• UDI-Device Identifier: 00613647000571
• UDI-Public: (01)00613647000571
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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-A202
• Device Catalogue Number: 23900530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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