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

Lot Number COV1120157

Device Problem Contamination (1120)

Patient Problem Burning Sensation (2146)

Event Date 01/28/2022

Event Type  Injury  

Event Description

Acon was made aware of the complaint via customer call on (b)(6) 2022 regarding a potential injury from the flowflex covid-19 antigen home test.The customer informed acon that she and her husband experienced burning sensation from the use of sample swabs included with the test kit, and a foaming reaction occurred when they tried to rinse out the nostril with saline solution.Per the complaint, it was unknown whether the sample swabs were contaminated before or after taken out of the sterile packaging.No further information about patient condition was available at the time of this mdr.The l/n of the test kit and the retention lot is available for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

Acon was made aware of the complaint via customer call on (b)(6) 2022 regarding a potential injury from the flowflex covid-19 antigen home test.The customer informed acon that she and her husband experienced burning sensation from the use of sample swabs included with the test kit, and a foaming reaction occurred when they tried to rinse out the nostril with saline solution.Per the complaint, it was unknown whether the sample swabs were contaminated before or after taken out of the sterile packaging.No further information about patient condition was available at the time of this mdr.The l/n of the test kit and the retention lot is available for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The final investigation yielded the following conclusion: batch records were reviewed for lot number cov1120157 and no abnormal issues were found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process.Based on the description, it might be the swab that caused an allergic reaction after the user took samples.It is considered as an isolated issue and may be related to a particular patient's susceptibility.Similar issues will be tracked and trended.

• Brand Name: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Type of Device: ANTIGEN DIAGNOSTIC FOR SARS-COV-2
• 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: 13500501
• MDR Text Key: 285711145
• Report Number: 2531491-2022-00001
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2022
• Device Lot Number: COV1120157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 05/09/2022
• 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): Other