FDA Adverse Event Malfunction Summary report: N

QUIDEL QUICK VUE OTC COVID 19 TEST

MDR report key: 18535558 · Received January 17, 2024

Report

Report Number
MW5150472
Event Type
Malfunction
Date Received
January 17, 2024
Date of Event
January 14, 2024
Report Date
January 14, 2024
Manufacturer
QUIDEL CORP.
Product Code
QKP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

WHILE RESEARCHING MY EXPIRED COVID 19 HOME TESTS, I CAME ACROSS YOUR LINK, HTTPS://WWW.FDA.GOV/MEDICAL-DEVICES/CORONAVIRUS-COVID-19-AND-MEDICAL-DEVICES/HOME-OTC-COVID-19-DIAGNOSTIC-TESTS#LIST IT DOES HAVE THE MANUFACTURER, TEST LOT NUMBER, ETC OF THE TESTS I TOOK, BUT THE INFORMATION HASN'T BEEN UPDATED SINCE SEPT OF 2022. AT THAT TIME, YOU, THE FDA EXTENDED THE EXPIRATION FROM 12-16 MONTHS, MAKING A DEC 2022 EXPIRATION GOOD UNTIL APRIL OF 2023. IT IS NOW JAN 2024 & I TESTED POSITIVE ON 1 TEST ABOUT 2 WEEKS AGO, BUT NEGATIVE ON A TEST TAKEN THIS PAST WEEK. I UNDERSTAND THAT THEY MAY BE ACTUALLY EXPIRED NOW, BUT CAN WE GET AN UPDATE STATING IF THERE'S BEEN MORE EXTENSIONS OR IF IT SHOULD BE RECYCLED WITHOUT BEING USED. I HAVE A PLASTIC GROCERY BAG OF AT-HOME COVID TESTS, ALL OF WHICH ARE EXPIRED. I ONLY CHECKED THE ONE I ACTUALLY USED AS OF RIGHT NOW. THE TEST I USED IS QUIDEL QUICKVUE LOT 2201003, AND EXPIRATION OF 2022-12-29. THANK YOU FOR YOUR ATTENTION TO THIS MATTER. ALSO, IT'S FRUSTRATING THAT I JUST NOW GOT COVID (MOST LIKELY GIVEN ALL THE SYMPTOMS, ETC.) AND NOW THERE'S LESS CURRENT INFO AVAIL THAN WHEN IT WAS 1ST SPREADING LIKE WILDFIRE, WHICH WHY DIDN'T WE QUARANTINE THE CITIES\COUNTIES OF THE 1ST FEW CASES IN THE VERY BEGINNING TO PREVENT BECOMING LIKE CHINA AND OTHER COUNTRIES? AND DID IT REALLY COME FROM A BAT AT THE MEAT MARKET OR A BAT AT OR FROM THE (B)(6) LABS? WE HAVEN'T FORGOTTEN THE FACT THAT OUR INITIAL QUESTION WAS SHRUGGED OFF. AND NO, I'M NOT BEING POLITICAL. I REALLY WANT TO KNOW THE TRUTH AND I DON'T EVEN REALLY LIKE THE PERSON THAT WAS IN OFFICE WHEN COVID CAME ANYWAY EVEN THOUGH THE ECONOMY WAS DOING PRETTY DARN GOOD BEFORE COVID (BC2 LOL). AGAIN, THANK YOU FOR YOUR ATTENTION TO THESE MATTERS! HAVE A HAPPY NEW YEAR. MAY WE ALL KEEP OUR HEALTH. REF REPORT: MW5150473.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2477482 QUIDEL QUICK VUE OTC COVID 19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORP. 2201003

Patients

Seq Age Sex Outcome Treatment
1 45 YR Female APPLE CIDER VINEGAR (PILL), FIBER AS NEEDED| DULOXOTINE| FISH OIL| FLONASE| GABAPENTIN | LEMON COUGH & SORE THROAT LOZENGES | MOBIC | MUCUS RELIEF DM | NASAL RELIEF FOR CONGESTION SPRAY | PANTOPRAZOLE| SALINE NASAL SPRAY| SOME ALLERGY PILL THAT I CAN'T RECALL NAME OF RT OFF| TUMERIC | UM| VIT B| VIT D