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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 N/A
Device Problem Unable to Obtain Readings (1516)
Patient Problem Insufficient Information (4580)
Event Date 04/02/2024
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 result (s).Bad brand-tests postive when neg.This test brand gave all false positives and ruined our week and an operation as we thought we were positive and the test showed 2 lines each time we took the test, but we were negative and finally got a different brand and saw the difference!!.
 
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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 Key19033911
MDR Text Key339264896
Report Number2531491-2024-00044
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
Report Date 04/03/2024
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 NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/03/2024
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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