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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 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Model Number L031-118B5
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Event Description
I used a flowflex covid-19 at-home antigen test and received suspicious results: on (b)(6) 2022 at 9am did the test per package directions, except also swabbed throat per guidance from research, and received a weak positive result. 3 hours later i performed a supervised naat test at university of washington (no throat swab, per supervised procedure), received a negative test result. On (b)(6) 2022 at 9am, did another rapid antigen test from another manufacturer (same procedure deviation above), received a negative result. On (b)(6) 2022 at 9am, did another flowflex rapid antigen test (same lot, same procedure) and received again a weak positive result. On (b)(6) 2022 i had nasal congestion. Nasal congestion resolved between the naat test on (b)(6) 2022 and rat test on (b)(6) 2022. No covid-specific symptoms appeared as they did during my previous covid infection (cough, lung capacity reduction, difficulty exercising). Fda safety report id# (b)(4).
 
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Brand NameFLOWFLEX COVID-19 ANTIGEN HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ACON LABORATORIES, INC.
MDR Report Key14052173
MDR Text Key289062855
Report NumberMW5108822
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00682607660261
UDI-Public(01)00682607660261
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/06/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL031-118B5
Device Catalogue Number660261
Device Lot NumberCOV2010020
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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