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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
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ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP Back to Search Results
Lot Number COV3090007
Device Problem Unable to Obtain Readings (1516)
Patient Problem Insufficient Information (4580)
Event Date 12/15/2023
Event Type  malfunction  
Event Description
Invalid result (s).Called in because she purchased 2 flowflex kits and both came back with invalid results.Only the t line appeared.She followed the directions exactly.She dispensed the sample into the s well and waited 15 minutes.She has since thrown the test cassettes away.The kits were purchased at cvs.
 
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.
 
Event Description
Invalid result (s).Called in because she purchased 2 flowflex kits and both came back with invalid results.Only the t line appeared.She followed the directions exactly.She dispensed the sample into the s well and waited 15 minutes.She has since thrown the test cassettes away.The kits were purchased at cvs.
 
Manufacturer Narrative
Final product manufacture and qc record for cov3090007.No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.The test results of retention samples from cov3090007 can meet the qc criteria.We have not found the complaint issue from the retained cassettes.The complaint is not verified.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.
 
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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 Key18369886
MDR Text Key331073855
Report Number2531491-2023-00752
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
PMA/PMN Number
EUA210494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberCOV3090007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/15/2023
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 Number1
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