MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. 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	Hormonal Imbalance (4495)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported an unspecified number of false negative results when testing patient samples using the hcg cassette rapid test, but was only able to provide information for one patient.The patient was tested as a screen prior to receiving a depo-provera injection for contraception.The patient tested negative on the hcg cassette rapid test and received the depo-provera injection.An unspecified urine pregnancy test was performed at another clinic 26 days later with a positive result.A quantitative blood hcg test was performed the following day with a result of 41,863 (units not specified), and the patient was diagnosed as pregnant.The patient's progesterone was determined to be low (5.8, units not specified); the patient was prescribed 200 mg progesterone per day.

• Brand Name: 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 92121
• MDR Report Key: 17263530
• Report Number: 3006984151-2023-00002
• Device Sequence Number: 5911383
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251(17)240531(10)HCG2062030
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/05/2023
• Report Date (Section F): 07/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: HCG2062030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/11/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 07/05/2023