MAUDE Adverse Event Report: ROCHE (DIST.) SD BIOSENSOR COVID-19 AT-HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number B04SCR20LEN02R0

Device Problem Defective Component (2292)

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

Event Date 07/24/2022

Event Type  malfunction  

Event Description

The instructions call for 4 drops to be dripped from the tube to the sample well on the test device.But the liquid did not come out as drops, but as foamy, wet bubbles, so i have no idea whether i applied the correct amount or not.(i followed all the written instructions to the letter.) so now i don't know if the faint positive is a valid result or not.Fda safety report id# (b)(4).

• Brand Name: COVID-19 AT-HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ROCHE (DIST.) SD BIOSENSOR
• MDR Report Key: 15112784
• MDR Text Key: 296768853
• Report Number: MW5111125
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 08800111707728
• UDI-Public: (01)08800111707728
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/21/2022
• Device Model Number: B04SCR20LEN02R0
• Device Catalogue Number: 9901-NCOV-10G
• Device Lot Number: 53K32U2T1
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White