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

Model Number FHC-202

Device Problem False Negative Result (1225)

Patient Problem Syncope/Fainting (4411)

Event Date 02/10/2024

Event Type  Injury  

Event Description

The customer reported receiving two false negative hcg results for one patient.The customer indicated the patient first presented on 10feb2024 for an epidural steroid injection due to neck pain.Prior to the procedure, a henry schein one step+ hcg combo 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.The patient then presented on 27feb2024 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, however the patient did receive two steroid injections for pain management after receiving negative hcg results.On 5mar2024, 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 3006984151-2024-00004-00 for the event which took place on 27feb2024.

Manufacturer Narrative

N/a.

• Brand Name: HENRY SCHEIN HCG COMBO
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• MDR Report Key: 19154078
• MDR Text Key: 340729424
• Report Number: 3006984151-2024-00005
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024123
• UDI-Public: (01)10304040024123(17)250108(10)0000667239
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024,04/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-202
• Device Catalogue Number: 9004075
• Device Lot Number: 0000667239
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2024
• Distributor Facility Aware Date: 03/26/2024
• Device Age: 14 MO
• Date Report to Manufacturer: 03/26/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female