MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL RAPID TEST HCG CASSETTE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: was entered as 1mar2025 as the customer was only able to indicate the events were around the week of 9mar2025.Preliminary investigation findings: 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.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 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.Please note: urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
Event or Problem Description
The customer reported receiving a total of 4 false positive hcg results using cardinal rapid hcg test cassettes for 4 patients.It was reported that these events took place sometime around the week of (b)(6) 2025, however specifics were unavailable.The second patient presented for an unspecified reason.The patient was tested and a positive hcg result was obtained.A retest was performed using another device from the same kit which yielded a negative result.Although requested, no further information was provided.No adverse event reported.See mdr 2027969-2025-00082 and 2027969-2025-00084 for patient 1 and 3 respectively.The positive result obtained by the fourth patient has been deemed not reportable as the customer deviated from the package insert, therefore a product malfunction was not determined, and no adverse events were reported.Therefore only 3 mdrs are being filed for this event.
Additional Manufacturer Narrative
B3 - date of event: was entered as 1mar2025 as the customer was only able to indicate the events were around the week of 9mar2025.Investigation conclusion: retained and returned 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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention and 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 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.Please note: urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
Event or Problem Description
The customer reported receiving a total of 4 false positive hcg results using cardinal rapid hcg test cassettes for 4 patients.It was reported that these events took place sometime around the week of mar.9th, 2025, however specifics were unavailable.The second patient presented for an unspecified reason.The patient was tested and a positive hcg result was obtained.A retest was performed using another device from the same kit which yielded a negative result.Although requested, no further information was provided.No adverse event reported.See mdr 2027969-2025-00082 and 2027969-2025-00084 for patient 1 and 3 respectively.The positive result obtained by the fourth patient has been deemed not reportable as the customer deviated from the package insert, therefore a product malfunction was not determined, and no adverse events were reported.Therefore only 3 mdrs are being filed for this event.

• Brand Name: CARDINAL RAPID TEST HCG CASSETTE
• 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: 21758681
• Report Number: 2027969-2025-00083
• Device Sequence Number: 8463326
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251(17)260327(10)0000857017
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• 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): 04/28/2025

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: 03/27/2026
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: 0000857017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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