MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP

Model Number L031-118B5

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 07/17/2022

Event Type  Injury  

Event Description

I was using at home test and getting negative results after exposure.Ended up with 103.2 fever and went to er.Tested positive at er, came home same day, used at home test again just to see accuracy, still getting negative result.Getting this sick could have been prevented with accurate test at home.Fda safety report id# (b)(6).

Manufacturer Narrative

This report is revised to a follow-up report filed by manufacturer in response to an initial mdr event reported by an end user (mw5110961).The following fields are updated: b4 "date of this report" - updated to date of this follow-up report g6 "type of report" - revised to "follow-up report #: 1" h2 "if follow-up, what type?" - added "correction" and "response to fda request" h10 "additional narrative/data" - added "manufacturer's narrative.".

Event Description

I was using at home test and getting negative results after exposure.Ended up with 103.2 fever and went to er.Tested positive at er, came home same day, used at home test again just to see accuracy, still getting negative result.Getting this sick could have been prevented with accurate test at home.Fda safety report id# (b)(6).

Manufacturer Narrative

In this follow-up report, the following information has been updated from the previous report upon completion of the internal investigation.The following fields are updated: b4 "date of this report" - updated to date of this follow-up report g6 "type of report" - revised to "follow-up report #: 2" h2 "if follow-up, what type?" - updated to "additional information" and "device evaluation" h3 "device evaluated by manufacturer?" - the retention lot has been evaluated by manufacturer h6 "adverse event problem" - added "investigation findings" and "investigation conclusions" per investigation.H10 "additional narrative/data" - added "manufacturer's narrative.

Event Description

I was using at home test and getting negative results after exposure.Ended up with 103.2 fever and went to er.Tested positive at er, came home same day, used at home test again just to see accuracy, still getting negative result.Getting this sick could have been prevented with accurate test at home.Fda safety report id# (b)(6).

• Brand Name: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Type of Device: ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• Manufacturer (Section G): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• Manufacturer Contact: qiyi xie ; 5850 oberlin drive #340; san diego, CA 92121 ; 8588758011
• MDR Report Key: 15211119
• MDR Text Key: 297714076
• Report Number: 2531491-2022-00009
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: EUA210494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L031-118B5
• Device Catalogue Number: 660261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female