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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 COV3090012
Device Problem Unable to Obtain Readings (1516)
Patient Problem Insufficient Information (4580)
Event Date 02/23/2024
Event Type  malfunction  
Event Description
Invalid results.The customer performed the test procedure correctly and neither the control (c) nor the test (t) lines appeared on the test cassette.The customer stated that the test kits were purchased from 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).Invalid results.The customer performed the test procedure correctly and neither the control (c) nor the test (t) lines appeared on the test cassette.The customer stated that the test kits were purchased from cvs.
 
Manufacturer Narrative
Final product manufacture and qc record for (b)(6).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 (b)(6)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.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.
 
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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 Key18822949
MDR Text Key336860326
Report Number2531491-2024-00033
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 03/01/2024
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 NumberCOV3090012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/23/2024
Initial Date FDA Received03/01/2024
Supplement Dates Manufacturer Received02/23/2024
Supplement Dates FDA Received03/11/2024
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 Number1
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