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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Hormonal Imbalance (4495)

Event Date 03/09/2023

Event Type  Injury  

Event 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
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego 92121
• MDR Report Key: 17263530
• MDR Text Key: 318578806
• Report Number: 3006984151-2023-00002
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 07/05/2023
• Distributor Facility Aware Date: 04/11/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: Black Or African American