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

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a false negative result when testing a patient sample with the cardinal hcg cassette rapid test.Following the negative result, the patient was sent for a ct scan and it was determined that the patient had appendicitis.The patient was sent to the er where labs were completed with a result of 151 miu/ml; the patient was determined to be pregnant.No adverse outcomes were reported as a result of the ct scan, however due to the potential for damage to the fetus this will be considered an other serious/important medical event.

• Brand Name: CARDINAL HCG CASSETTE RAPID TEST
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• MDR Report Key: 19840907
• Report Number: 3006984151-2024-00006
• Device Sequence Number: 7666414
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024
• Report Date (Section F): 07/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: 0000695450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2024
• Date Report to Manufacturer: 06/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 07/26/2024