FDA Adverse Event Malfunction Summary report: N

FLOWFLEX COVID-19 ANTIGEN HOME TEST

MDR report key: 13117854 · Received December 29, 2021

Report

Report Number
MW5106351
Event Type
Malfunction
Date Received
December 29, 2021
Date of Event
December 11, 2021
Report Date
December 27, 2021
Manufacturer
ACON LABORATORIES, INC. / MAQ-OPS, S. DE R.L.
Product Code
QKP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PURCHASED TWO "FLOWFLEX" ANTIGEN COVID HOME TESTS, UNDER BRAND NAME ACON FROM (B)(6) ON (B)(6) 2021. CAREFULLY FOLLOWED THE INSTRUCTIONS TO TAKE ONE A COUPLE HOURS LATER AND IT CAME BACK POSITIVE. TOOK THE SECOND ABOUT ONE HOUR LATER AND IT ALSO CAME BACK POSITIVE. THIS CAME AS A SURPRISE AS I HAD NO SYMPTOMS, NO CONTACT WITH ANYONE WHO HAD TESTED POSITIVE, WAS EXTREMELY ISOLATED AND WORE A MASK IN PUBLIC FOR THE TWO WEEKS PRIOR. THE FOLLOWING MORNING I WENT TO A TESTING SITE TO RECEIVE AN ABBOT BINAXNOW RAPID TEST, WHICH RETURNED NEGATIVE, THEN TOOK ANOTHER ABBOT BINAXNOW RAPID TEST AT HOME AN HOUR LATER, WHICH ALSO RETURNED NEGATIVE. LAST, I WENT TO A TEST SITE IN (B)(6) OPERATED BY (B)(6) A COUPLE HOURS LATER AND RECEIVED A LAMP TEST, WHICH RETURNED NEGATIVE THE FOLLOWING DAY. THUS, I BELIEVE THESE TWO FLOWFLEX / ACON TESTS WERE FAULTY, RETURNING FALSE POSITIVES. IN THE FOLLOWING TWO WEEKS I HAVE NOT DEVELOPED ANY SYMPTOMS, AND I HAVE TESTED NEGATIVE ONCE MORE ON A ABBOT BINAXNOW TEST ON (B)(6) 2021. THE LOT NUMBER FOR BOTH FLOWFLEX TESTS IS COV1100069, WITH AN EXPIRATION DATE OF 10/21/2022. I HAVE RETAINED BOTH BINAXNOW TESTS AND PACKAGING, AND HAVE PHOTOS/EMAILS TO VERIFY THE OTHER NEGATIVE RAPID/LAMP TESTS, SO PLEASE LET ME KNOW IF YOU NEED MORE INFORMATION. TEST 1 TAKEN AT HOME APPROX 5PM, TEST 2 TAKEN AT HOME APPROX 6PM. FDA SAFETY REPORT ID#:(B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2013982 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. / MAQ-OPS, S. DE R.L. COV1100069
2013986 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. / MAQ-OPS, S. DE R.L. COV1100069

Patients

Seq Age Sex Outcome Treatment
1 31 YR Male