MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. RAPID RESULT COVID-19 TEST E-013306-BNX; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Type  malfunction  

Event Description

We tested our family of 4 at a public rapid testing site (local fire station) available on (b)(6) 2020 in (b)(6).This first test was taken at 3:06pm.Within 20 minutes we got the result that our son received a positive result 2 days later on (b)(6) at 11:15 we tested him pcr form through our local hospital (b)(6) and got the results back as being not detected.Being parents, we wanted to know exactly what was happening with our son.Due to this we got the whole family tested again a week later on (b)(6) 2021 at 9:04 and all had negative results.Because of what's listed above, i feel that we were given a false positive result for the first test.Fda safety report id # (b)(4).

• Brand Name: RAPID RESULT COVID-19 TEST E-013306-BNX
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; unk
• MDR Report Key: 11177316
• MDR Text Key: 227495512
• Report Number: MW5098830
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1