MAUDE Adverse Event Report: WONDFO USA CO., LTD. PREVIEW STREP A TEST KIT; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Lot Number B03920702 A

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  malfunction  

Event Description

I purchased the preview strep a test kit (10 tests) and when i went to give my daughter one of the tests, the bottle marked 'a - extraction reagent' was empty.

• Brand Name: PREVIEW STREP A TEST KIT
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): WONDFO USA CO., LTD.
• MDR Report Key: 16573043
• MDR Text Key: 311670501
• Report Number: MW5115811
• Device Sequence Number: 1
• Product Code: GTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: B03920702 A
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White