FDA Adverse Event Injury Summary report: N

WALGREENS TRUE METRIX

MDR report key: 17462815 · Received August 3, 2023

Report

Report Number
MW5120600
Event Type
Injury
Date Received
August 3, 2023
Date of Event
July 26, 2023
Report Date
August 1, 2023
Manufacturer
TRIVIDIA HEALTH, INC.
Product Code
NBW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I WAS IN THE HOSPITAL WITH PNEUMONIA FOR A WEEK AND MY BLOOD GLUCOSE LEVEL WENT DANGEROUSLY HIGH. I WAS PUT ON INSULIN IN AND OUT OF THE HOSPITAL. I HAD PURCHASED TWO WALGREENS TRUE METRIX MONITORS (ONE FOR MY ADOPTIVE FAMILY AS WELL). I HAD TO SEE MY GP (GENERAL PRACTIONER) AS PART OF MY RELEASE ABOUT MY BLOOD SUGAR LEVELS. I NOTICED THAT MY READINGS WERE DIFFERENT FROM THE HOSPITALS. ON (B)(6) 2023, AT THE DR'S OFFICE, I WAS GIVEN THE IN-OFFICE TEST. I CHECKED WITH THE MA, SHE SAID THAT THEY HAVE TO HAVE THEIR DEVICES CERTIFIED AND SHE TOLD ME THAT THEY RECORD THE LOT NUMBERS AND DATE CODES OF THE TEST STRIPS ON THE PATIENT¿S FILE. MY READING WAS 148. TEST STRIPS LOT: 2B5235S, EXP 2024-10-31. WITHIN NINE MINUTES, I WAS IN MY CAR, TESTING BOTH UNITS. BOTH UNITS READ 178 EXACTLY. THAT IS 30 POINTS DIFFERENT FROM THE TRUE READING FROM THE HOSPITAL. I WAS TOLD IF MY READING WAS ABOVE 300 OR BELOW 70, I NEEDED TO GO TO THE HOSPITAL. FOR EXAMPLE, IF BOTH OF THESE TWO MONITORS READ 90, THAT WOULD BE A GREAT READING. HOWEVER, SINCE THEY ARE 30 POINTS OFF, MY READING IS ACTUALLY 60. THAT WOULD MEAN THAT I SHOULD GO TO THE HOSPITAL. IF I NEVER TOOK BOTH OF THESE METERS, I WOULD NOT HAVE KNOWN AND COULD HAVE HAD LIFE THREATENING RESULTS AND NOT KNOWN IT. ON (B)(6) 2023, I CALLED TRUE METRIX MANUFACTURER, TRIVDIA HEALTH, PH. 1-800-803-6025. I SPOKE TO A YOUNG LADY IN CUSTOMER SERVICE AND EXPLAINED MY PROBLEM. I DO NOT BLAME HER FOR HER RESPONSE, AS I COULD TELL THAT SHE WAS READING IT. SHE SAID THAT SINCE THE HOSPITAL DEVICE WAS DIFFERENT THAN USING A TRUE METRIX DEVICE, THERE WOULD BE A DIFFERENCE. I ADVISED HER THAT 30 POINTS WAS NOT ACCEPTABLE. I ASKED FOR HER SUPERVISOR TO CALL ME. (B)(4), A A TEAM LEADER, CALLED ME. I EXPLAINED THAT THIS WAS A LIFE-THREATENING SITUATION. IT APPEARED TO ME THAT SHE DID NOT SEEM TO THINK THAT THIS WAS A BIG DEAL. PERHAPS I AM WRONG. SHE SAID THAT SHE WOULD GLADLY REPLACE BOTH UNITS. I SAID THAT I WANTED NO PART OF THESE PRODUCTS AS I THINK THAT THEY COULD CAUSE SOMEONE'S DEMISE. AS I TOLD HER, THEY ARE LOSING TWO CUSTOMERS BUT WE ARE SAVING OUR LIVES. SHE GAVE ME A CASE NUMBER OF (B)(4). I HAVE BOTH MONITORS AND THE TEST STRIPS THAT YOU CAN HAVE FOR YOUR TESTING PURPOSES. IF I AM CORRECT, I THINK THAT PEOPLE NEED TO BE WARNED OF DANGER WITH THESE MONITORS. MY NAME IS (B)(6). DR'S BLOOD GLUCOSE MONITOR WAS 148, RECENTLY CERTIFIED AS ACCURATE. THE TWO TRUE METRIX RESULTS WITHIN NINE MINUTES WAS 178. REFERENCE REPORT: MW5120601.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
795944 WALGREENS TRUE METRIX SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH, INC. RE4TVH09

Patients

Seq Age Sex Outcome Treatment
1 73 YR Male Life Threatening