MAUDE Adverse Event Report: SEKISUI DIAGNOSTICS, LLC OSOM HCG COMBO TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Lot Number 221418

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2022

Event Type  malfunction  

Event Description

The urine was not able to pass through cassette to result on pregnancy test.

• Brand Name: OSOM HCG COMBO TEST
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): SEKISUI DIAGNOSTICS, LLC; 6740 cobra way; san diego CA 92121
• MDR Report Key: 16214011
• MDR Text Key: 307780247
• Report Number: 16214011
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2022,12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 221418
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1