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

Lot Number COV1120162

Device Problem Unclear Information (4052)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

The current complaint is related to performance issue or device malfunction, but no information was provided for acon to conduct an investigation.Any additional information received by acon may be provided to fda in a follow up mdr.

Event Description

False positive/negative result (s).Purchased flowflex antigen home test lot cov1120162, expiration date indicated on a box is 2023-09-16.In the box i found that both extraction buffer and test cassettes are long expired: extraction buffer tubes, lot 211125026, exp.2023-05-24 and the test cassettes lot cov1120162, exp.2021-12-16.

Event Description

False positive/negative result (s).Purchased flowflex antigen home test lot cov1120162, expiration date indicated on a box is 2023-09-16.In the box i found that both extraction buffer and test cassettes are long expired: extraction buffer tubes, lot 211125026, exp.2023-05-24 and the test cassettes lot cov1120162, exp 2021-12-16.

Manufacturer Narrative

Customer was sent email on 08/24/2023 providing her the link to fda website regarding the extension of the expiration dates and to provide her address if she would like replacements sent to her.Customer has not responded.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.The following fields are updated: b4, "date of this report" - date of follow-up report g6, "type of report" - follow-up #1.H2, "if follow-up, what type?" - updated to "additional information" and "device evaluation" h6 "adverse event problem" - event problem and evaluation codes such as "investigation findings" and "investigation.Conclusions" are added per investigation.H10 "additional narrative/data" - added manufacturer's narrative.

• 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
• MDR Report Key: 17704709
• MDR Text Key: 322939176
• Report Number: 2531491-2023-00643
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: COV1120162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 11/17/2023
• 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