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

Lot Number COV2030003

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Issue with swab/component(s).The customer stated that the nasal swab tip came off inside their nostril while they were performing the test procedure and that it took roughly 5 minutes to dislodge the nasal swab tip from their nostril.The customer confirmed that they did not sustain any injuries.

Manufacturer Narrative

The current complaint is pending investigation from our contract manufacturer, and we will provide follow up mdr upon investigation completion such as review of batch records or testing of retention samples.Any additional information received by acon may be provided to fda in a follow up mdr.

Manufacturer Narrative

No abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process was complied with the dmr.We checked the batch records of the reported lot cov2020185 and the dmr for the product.Supplier jiangsu hanheng medical technology co., ltd., was informed to investigate this complaint.Based on the investigation, this issue was attributed to the individual worn molds, leading to thimble problem, so that the swab tip was not welded successfully onto the swab rod.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.

Event Description

Issue with swab/component (s).The customer stated that the nasal swab tip came off inside their nostril while they were performing the test procedure and that it took roughly 5 minutes to dislodge the nasal swab tip from their nostril.The customer confirmed that they did not sustain any injuries.

• 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: 18155139
• MDR Text Key: 328420215
• Report Number: 2531491-2023-00723
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2023
• Device Lot Number: COV2030003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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