FDA Adverse Event Malfunction Summary report: N

COVID-19 NASAL/ NASOPHARYNX

MDR report key: 10095893 · Received May 27, 2020

Report

Report Number
MW5094700
Event Type
Malfunction
Date Received
May 27, 2020
Date of Event
April 4, 2020
Report Date
May 26, 2020
Manufacturer
BIOREFERENCE LABORATORIES / OPKO HEALTH, INC.
Product Code
QJR
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM REPORTING A PROBABLE FALSE NEGATIVE FROM THE BIOREFERENCE LABORATORIES NASAL/ NASOPHARYNX COVID-19 PCR TEST. I FIRST HAD COVID-RELATED SYMPTOMS (FEVER, HEADACHE) ON (B)(6) AND WAS TESTED ON (B)(6) AT THE (B)(6) DRIVE THROUGH TESTING SITE AT (B)(6). THE RESULT CAME BACK ON (B)(6) AS 'NOT DETECTED'. IN TOTAL, I HAD FIVE DAYS OF FEVER ((B)(6)). NOTE THAT MY DAD, WHOM I LIVE WITH AND CARED FOR, HAD BECOME SICK ON (B)(6), TESTED POSITIVE FOR COVID ON (B)(6) (ALTHOUGH THE RESULT WAS NOT RECEIVED UNTIL (B)(6)), AND WAS SENT TO THE HOSPITAL ON (B)(6), THE SAME DAY I FELL ILL. MY MOTHER ALSO FELL ILL ON (B)(6) AND TESTED POSITIVE FOR COVID (ON A BIOREFERENCE LABORATORIES TEST) ON (B)(6). BOTH OF MY PARENTS HAD CASES REQUIRING HOSPITALIZATION. I SUBSEQUENTLY WAS TESTED FOR SARS-COV-2 AB IGG ON (B)(6) WHICH CAME BACK POSITIVE (TEST ORDERED AND COLLECTED BY AN URGENT CARE AND PROCESSED BY (B)(6)). I BELIEVE MY TEST WAS A FALSE NEGATIVE. I AM NOT SURE IF THAT WAS CAUSED BY AN ISSUE WITH THE TEST ITSELF, OR BECAUSE THE VIRAL LOAD WAS NOT HIGH ENOUGH (MY CASE WAS RELATIVELY MILD). FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
554428 COVID-19 NASAL/ NASOPHARYNX REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR BIOREFERENCE LABORATORIES / OPKO HEALTH, INC.

Patients

Seq Age Sex Outcome Treatment
1 28 YR