FDA Adverse Event Malfunction Summary report: N

CELLEX QSARS-COV-2 IGG/IGM RAPID TEST

MDR report key: 10384374 · Received August 7, 2020

Report

Report Number
MW5095957
Event Type
Malfunction
Date Received
August 7, 2020
Date of Event
August 6, 2020
Report Date
August 6, 2020
Manufacturer
CELLEX
Product Code
QKO
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I BEGAN EXPERIENCING SYMPTOMS OF COVID ON OR AROUND (B)(6), STARTING WITH AN INTENSE SORE THROAT AND UNEXPECTED SORENESS IN CHEST AREA, FOLLOWED BY MILD SHORTNESS OF BREATH, A FEVER THAT REACHED 101, AND TOTAL LOSS OF SENSE OF SMELL. AFTER EXPERIENCING SYMPTOMS FOR APPROXIMATELY A WEEK, I WAS TESTED FOR COVID ON (B)(6). BY THAT TIME, ALL SYMPTOMS, INCLUDING FEVER, HAD DISAPPEARED. (IN OTHER WORDS, I WAS SYMPTOMATIC FROM APPROXIMATELY (B)(6).) THE TEST RESULTS CAME BACK POSITIVE, AS EXPECTED. THIS TEST WAS SARS-COV-2 RNA, QL, RT PCR OFFERED AT A NEARBY (B)(6) IN (B)(6). ON (B)(6), I WAS TESTED AGAIN, AT (B)(6) MALL IN (B)(6), AND AGAIN THE TEST WAS POSITIVE. ON THE SAME DATE, I WAS ALSO TESTED FOR ANTIBODIES. BOTH IGG AND IGM CAME BACK NEGATIVE. THIS WAS THE CELLEX QSARS-COV-2 IGG/IGM RAPID TEST. TODAY, (B)(6), I WAS TESTED FOR INFECTION AGAIN. I DO NOT HAVE THOSE RESULTS YET. I WAS ALSO TESTED AGAIN FOR ANTIBODIES, AGAIN VIA THE CELLEX RAPID TEST. TODAY IT CAME BACK POSITIVE FOR BOTH IGG AND IGM. AS FAR AS I CAN TELL, THIS SERIES OF RESULTS FALLS OUTSIDE THE EXPECTED PERFORMANCE/BEHAVIOR. HAVING HAD NOT ONE BUT TWO POSITIVE TESTS, CORRESPONDING WITH SYMPTOMS BEGINNING APPROXIMATELY (B)(6), I WOULD HAVE EXPECTED THE FIRST ANTIBODY TEST, ON (B)(6), TO HAVE SHOWN POSITIVE RESULTS, GIVEN THAT I HAD BEEN INFECTED FOR AT LEAST 25 DAYS AT THAT POINT AND HAD RECOVERED FROM SYMPTOMS NEARLY THREE WEEKS PRIOR. CERTAINLY IT'S POSSIBLE THAT THE WAY MY BODY HAS RESPONDED TO COVID IS ABNORMAL. HOWEVER, IT'S ALSO POSSIBLE THAT THE TEST CONTINUES TO BE UNRELIABLE, WHICH IS THE REASON I THOUGHT I'D SHARE MY EXPERIENCE HERE TODAY. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
846842 CELLEX QSARS-COV-2 IGG/IGM RAPID TEST REAGENT, CORONAVIRUS SEROLOGICAL QKO CELLEX

Patients

Seq Age Sex Outcome Treatment
1 34 YR