FDA Adverse Event Malfunction Summary report: N

ONETOUCH VERIO FLEX

MDR report key: 21549560 · Received March 7, 2025

Report

Report Number
MW5167403
Event Type
Malfunction
Date Received
March 7, 2025
Date of Event
October 29, 2024
Report Date
March 2, 2025
Manufacturer
UNK
Product Code
NBW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THE DATE THE PROBLEM OCCURRED ENTERED ABOVE IS THE DATE I BOUGHT IT. I HAVE SEVERAL TEST DATES THE PRODUCT FAILED ME. I HAD A ONETOUCH BLOOD TESTING DEVICE PREVIOUSLY FAIL ME. I WENT THROUGH HELL WITH THIS COMPANY AND FINALLY GOT A NEW DEVICE. BOTH MADE IN CHINA, AND I HAD TO DEAL W/ CHINESE-THEY REFUSED ME SOMEONE IN THE U.S. THE NEW DEVICE IS DOING THE SAME THING THE OLD DEVICE DID-A FEW EXAMPLES: (B)(6) 2025 2:06 PM 136, 118 2:08 PM, (B)(6) 2025, 124 5:48 AM, 114 5:51 AM, (B)(6) 2025 140 2:32 PM, 98 2:34 PM, (B)(6) 2025 139 2:36 PM, 114 2:38 PM, (B)(6) 2024 126 8:07 AM, 112 8:09 AM, - YOU GET THE IDEA. SO, THIS MACHINE KEEPS DOING THIS ON A LOT OF MY READINGS JUST LIKE THE OLD MACHINE DID. I HAVE THESE TYPES OF READINGS EVERY MONTH SINCE I STARTED USING THE NEW MACHINE, WHICH WAS ON (B)(6) 2024. THE BOX ALSO SAYS IT WILL SHOW A COLOR TO INDICATE IF THE READING IS LOW, IN RANGE, OR HIGH, AND MY MACHINE DOES NOT DO THAT. ADDITIONALLY, A LOT OF MY TEST STRIPS ARE DEFECTIVE. THE CHINESE BASICALLY TOLD ME, TOO BAD, CAN'T GIVE YOU ANY REPLACEMENT TEST STRIPS. DO YOU KNOW HOW EXPENSIVE THOSE ARE? MY NEW MACHINE: ONETOUCH VERIO FLEX MFG: 2024-07-17, (B)(4)-THE LABEL ON THE SIDE HAS A TON OF NUMBERS/LETTERS. I DON'T KNOW WHAT ELSE YOU WOULD NEED. MY DAD IS (B)(6) YEARS OLD AND HE HAS THE SAME TEST MACHINE. I AM VERY WORRIED ABOUT BOTH OF US. WE ALL KNOW HOW MUCH CHINA HATES AMERICANS, AND IT SHOWS BY THE RUDE CHINA GUY I SPOKE TO. WE BOTH NEED ACCURATE READINGS, AND I TRULY BELIEVE THIS IS ALL DONE TO HARM AMERICANS. I AM NOT CERTAIN ON SOME OF THE ANSWERS TO YOUR QUESTIONS AND NO WHERE DO YOU ASK FOR MY INFORMATION - "HOW ON EARTH ARE YOU GOING TO GET IN TOUCH WITH ME?"

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2144204 ONETOUCH VERIO FLEX SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW UNK AW 07063908A

Patients

Seq Age Sex Outcome Treatment
1 68 YR Female Other