FDA Adverse Event Malfunction Summary report: N

FLOWFLEX COVID-19 ANTIGEN HOME TEST

MDR report key: 20071999 · Received August 26, 2024

Report

Report Number: 2531491-2024-00095
Event Type: Malfunction
Date Received: August 26, 2024
Date of Event: August 14, 2024
Report Date: August 26, 2024
Manufacturer: ACON LABORATORIES, INC.
Product Code: QKP
PMA / PMN Number: EUA210494
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

FALSE POSITIVE RESULTS. WE GOT A CALL FROM A FLOWFLEX CUSTOMER THAT IS CLAIMING THAT THAT 1/3 OF A CASE OF 200 KITS (66) KITS , HAVE READ FALSE POSITIVE. SO, THIS IS AN OUT OF BOX ISSUE. THE CUSTOMER CALLED FROM AN ADULT CARE FACILITY AND CLAIMS THEY PERFORMED FLOWFLEX TESTS THAT WERE POSITIVE, AND RETESTED RIGHT AWAY WITH ANOTHER BRAND AND THEY RESULTS WERE NEGATIVE. THE CUSTOMER DID NOT HAVE ANY TEST CASSETTES OFF THE 66 SUSPECTED TEST KITS, SO WE CANNOT CONFIRM WITH ANY PICTURES. CUSTOMER IS REQUESTING ACON LABS REPLACE THE FULL CASE OF 200 THEY STILL HAVE FROM THE SAME LOT # AND REPLACE THE 1/3 (66) BOXES OF THE CASE THEY CLAIM WERE FAULTY TEST KITS. I ADVISED THE CUSTOMER THAT I NEED TO FORWARD THIS INFORMATION TO THE APPROPRIATE DEPARTMENT FOR REVIEW. CUSTOMER WILL WAIT FOR AN EMAIL RESPONSE FROM ACON LABS REGARDING THIS MATTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
968073	FLOWFLEX COVID-19 ANTIGEN HOME TEST	ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP	QKP	ACON LABORATORIES, INC.		COV3090017

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown