MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG DEVICE (SERUM/URINE); VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation findings: retained devices from the reported lot number were tested with hcg-negative clinical urine and 25miu/ml positive cut-off samples.The results were read at 3 minutes and all devices tested with negative samples yielded valid negative results and all devices tested with positive 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 low levels of hcg (less than 50 miu/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 urine or serum 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 or serum 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 a total of 2 false positive hcg results while testing alere hcg (serum/urine) devices on two different patients.The second patient presented on (b)(6) 2024 prior to undergoing an unspecified surgical procedure.The patient provided a fresh urine sample was provided, which was tested, and the results were read at 3 minutes.A faint positive result was reported.As a result of the positive result, retesting was performed using a different device from the same kit and a negative hcg result was obtained.The customer reported no adverse events occurred as a result of the false positive result.No further information was provided.See mdr 2027969-2024-00217 for the mdr for the first patient.
Additional Manufacturer Narrative
"h3 - device evaluated by mfg?", "h6 - adverse event problem", and "h11 - additional mfg narrative" were updated to include return testing.Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative clinical urine and 25miu/ml positive cut-off urine samples.The results were read at 3 minutes and all devices tested with negative samples yielded valid negative results and all devices tested with positive 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 or returned 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 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 urine or serum 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 or serum 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 a total of 2 false positive hcg results while testing alere hcg (serum/urine) devices on two different patients.The second patient presented on (b)(6) 2024 prior to undergoing an unspecified surgical procedure.The patient provided a fresh urine sample was provided, which was tested, and the results were read at 3 minutes.A faint positive result was reported.As a result of the positive result, retesting was performed using a different device from the same kit and a negative hcg result was obtained.The customer reported no adverse events occurred as a result of the false positive result.No further information was provided.See mdr 2027969-2024-00217 for the mdr for the first patient.

• Brand Name: ALERE HCG DEVICE (SERUM/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: 20958916
• Report Number: 2027969-2024-00220
• Device Sequence Number: 12823052
• Product Code: JHI
• UDI-Device Identifier: 10815845020116
• UDI-Public: (01)10815845020116(17)251219(10)0000825047
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• 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,Followup
• Report Date (Section B): 03/27/2025

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: 12/19/2025
• Device Model Number: FHC-202
• Device Catalogue Number: 92225
• Device Lot Number: 0000825047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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 Sex: Female