MAUDE Adverse Event Report: BIOREFERENCE LABORATORIES / OPKO HEALTH, INC. COVID-19 NASAL/ NASOPHARYNX; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem False Negative Result (1225)

Patient Problems Fever (1858); Headache (1880); Malaise (2359); Test Result (2695)

Event Date 04/04/2020

Event Type  malfunction  

Event Description

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).

• Brand Name: COVID-19 NASAL/ NASOPHARYNX
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): BIOREFERENCE LABORATORIES / OPKO HEALTH, INC.; 4400 biscayne blvd; miami FL 33137
• MDR Report Key: 10095893
• MDR Text Key: 192715669
• Report Number: MW5094700
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 68