FDA Adverse Event Injury Summary report: N

CUE HEALTH PCR AT-HOME MEDICAL COVID-19 TESTING DEVICE

MDR report key: 14694977 · Received June 14, 2022

Report

Report Number
MW5110303
Event Type
Injury
Date Received
June 14, 2022
Date of Event
May 5, 2022
Report Date
June 11, 2022
Manufacturer
CUE HEALTH, INC.
Product Code
QJR
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

SON SHOWED SIGNS OF COVID ON (B)(6) 2022 AND TESTS POSITIVE ON CUE HEALTH PCR DEVICE REPORTED TO EMPLOYER WHO HAD ME WORK. I TESTED AND MY HUSBAND BOTH TESTED NEGATIVE ON DEVICE. ON (B)(6) 2022 MY HUSBAND TESTED POSITIVE ON CUE HEALTH PCR DEVICE AND I TESTED NEGATIVE BUT BOTH OF US SHOWED VISIBLE AND OBVIOUS SYMPTOMS OF COVID; REPORTED TO EMPLOYER WHO ADVISED TO CONTINUE WORKING SINCE NEGATIVE RESULTS. ON (B)(6) 2022 I TESTED NEGATIVE, CONTINUED TO SHOW VISIBLE AND OBVIOUS SYMPTOMS, REPORTED TO EMPLOYER WHO ASSIGNED ME MORE WORK AND COMPLAINED AT MY ASKING FOR TIME OFF DUE TO EXHAUSTION AND SYMPTOMS; THREATENED TO TERMINATE EMPLOYMENT IF I DID NOT "BRING MY PROFESSIONAL SELF." HOURS LATER, SUPERVISOR SCHEDULE CALL TO SAY I WAS NOT BEING A GOOD FIT FOR THE COMPANY. ON (B)(6) 2022 I TESTED POSITIVE AND WAS INCREASINGLY MORE SICK INCLUDING HAVE BREATHING PROBLEMS (I HAVE ASTHMA). ON (B)(6) 2022 I OBTAINED A DOCTORS NOTE SO I COULD TAKE TIME OFF TO HEAL. ON (B)(6) 2022 EMPLOYER ASKED ME TO WORK WHILE AT THE SAME TIME SAYING I WAS SEPARATING; I AGAIN ASKED THEM TO PLEASE REFERRED TO MEDICAL NOTE AND LEAVE ME ALONE TO RECOVER. ON (B)(6) 2022 I PROVIDED NEW MEDICAL NOTE, EMPLOYER ACKNOWLEDGED AND SHARED THAT TELLING PEOPLE TO STOP USING LEGAL DOCUMENTS NOT PRODUCED BY A LICENSE ATTORNEY AND POTENTIALLY STOLEN FROM AUTHOR'S PRIOR EMPLOYER, TELLING AUDIT TEAM MEMBER TO CONTACT HR ON ANY QUESTIONS ABOUT MY "REMIT," AND REFERENCING EXTENSIVE WORK ASSIGNED AND DUE SAME DAY AS "LANDED ON MY DESK" WERE BASIS FOR CAUSE OF TERMINATING EMPLOYMENT. I AGAIN ASKED EMPLOYER TO STOP CONTACTING ME SO I COULD RECOVER AND PROVIDED NAME OF THIRD PARTY WHO COULD SERVE AS INTERMEDIARY/LEGAL REP WHILE I WAS RECOVERING AND ILL. EMPLOYER HAD THEIR OUTSIDE COUNSEL CONTACT ME DIRECTLY. I WAS EVENTUALLY PUT ON ANTIVIRALS. SINCE ANTIVIRAL CAN ONLY BE USED WITHIN A LIMITED TIME FROM FIRST SYMPTOMS, THE CUE PCR TESTING DEVICE'S FALSE NEGATIVE RESULTS PUT ME AT GREAT MEDICAL RISK. THE INACCURATE RESULTS I HAD RELIED ON PREVENTED ME FROM BEING ABLE TO GET TIME OFF AND MORE QUICKLY SEEKING APPROPRIATE MEDICAL HELP. THE DELAY AND FALSE NEGATIVE RESULTS DID/COULD HAVE JEOPARDIZED MY HEALTH. EMPLOYER IS CUE HEALTH; THEIR STAFF WHO LEARNED OF MY COVID WANTED SAMPLES FROM ME STARTING ON (B)(6) 2022 AND REVEALED THEY KNEW THEIR TESTING DEVICE WAS SHOW FALSE NEGATIVE RESULTS AND THAT I LIKELY HAD COVID DESPITE TESTING NEGATIVE ON THEIR DEVICE. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1659033 CUE HEALTH PCR AT-HOME MEDICAL COVID-19 TESTING DEVICE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC.
1659034 CUE HEALTH PCR AT-HOME MEDICAL COVID-19 TESTING DEVICE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC.

Patients

Seq Age Sex Outcome Treatment
1 47 YR Female Required Intervention| S| O