MAUDE Adverse Event Report: SEKISUI DIAGNOSTICS, LLC OSOM CARD PREGNANCY TEST; VISUAL, PREGNANCY

Lot Number 151478

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2016

Event Type  malfunction  

Event Description

The control line on the urine pregnancy test did not show.

• Brand Name: OSOM CARD PREGNANCY TEST
• Type of Device: VISUAL, PREGNANCY
• Manufacturer (Section D): SEKISUI DIAGNOSTICS, LLC; 4 hartwell pl; lexington MA 02421
• MDR Report Key: 5963461
• MDR Text Key: 55149979
• Report Number: 5963461
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/30/2017
• Device Lot Number: 151478
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1