MAUDE Adverse Event Report: ALERE SAN DIEGO, INC HENRY SCHEIN HCG URINE CASSETTE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The customer reported receiving two false negative hcg results for one patient.The customer indicated the patient first presented on (b)(6) 2024 for an epidural steroid injection due to neck pain.Prior to the procedure, a henry schein hcg combo device was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.The patient then presented on (b)(6) 2024 for an additional epidural steroid injection.Prior to the procedure, a henry schein one step+ hcg urine cassette test was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.No adverse events were reported.On (b)(6) 2024, the patient presented to the emergency room after fainting.The cause of the fainting was not reported, however a pregnancy test was performed at the facility which noted the patient was 5 weeks pregnant.Although requested, no further information was provided.See mdr 3006984151-2024-00005-00 for the event which took place on (b)(6) 2024.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE
• 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: 19142208
• Report Number: 3006984151-2024-00004
• Device Sequence Number: 7862047
• Product Code: JHI
• UDI-Device Identifier: 10304040024109
• UDI-Public: (01)10304040024109(17)250223(10)0000692274
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2024
• Report Date (Section F): 04/11/2024

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 Expiration Date: 02/23/2025
• Device Model Number: FHC-102
• Device Catalogue Number: 9004073
• Device Lot Number: 0000692274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/21/2024
• Device Age: 13 MO
• Date Report to Manufacturer: 03/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• 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 Age: 30 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/11/2024