FDA Adverse Event Malfunction Summary report: N

DARIO BLOOD GLUCOSE MONITORING SYSTEM

MDR report key: 11923009 · Received June 2, 2021

Report

Report Number
3010606081-2021-00014
Event Type
Malfunction
Date Received
June 2, 2021
Date of Event
May 3, 2021
Report Date
June 2, 2021
Manufacturer
LABSTYLE INNOVATIONS LTD.
Product Code
NBW
PMA / PMN Number
K150817
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON MAY 3RD, THE USER CONTACTED DARIO TO REPORT A HIGH BLOOD GLUCOSE (BG) READING. THE USER REPORTED THAT IN 2020, SHE RECEIVED A BG READING IN THE 400 MG/DL RANGE ON HER DARIO METER. DUE TO THIS ELEVATED READING, THE USER WENT TO THE HOSPITAL, WHERE HER BG LEVEL WAS TESTED WITH THE HOSPITAL'S METER AND WAS FOUND TO READ 103 MG/DL. FOLLOWING THE ABOVE IN FEBRUARY 2021, THE USER BOUGHT ANOTHER DARIO METER AND STRIPS. THE USER REPORTED THAT SHE TESTED HER BG LEVEL WITH THE NEW DARIO METER AND RECEIVED A BG READING OF 250 MG/DL COMPARED TO A READING IN THE 100 MG/DL RANGE WITH HER NON-DARIO METER. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER HAD BEEN USING A CARTRIDGE OF STRIPS FOR BOTH OF HER DARIO METERS THAT SHE OPENED A COUPLE OF MONTHS PRIOR TO THE BG TESTING, AND THEREFORE WAS USING AN EXPIRED CARTRIDGE OF STRIPS. AS PER DARIO'S TEST STRIPS LABELING "USE WITHIN ONE MONTH FROM FIRST OPENING THE CARTRIDGE FOIL". DARIO'S REPRESENTATIVE EXPLAINED TO THE USER THAT STRIPS THAT HAVE BEEN OPENED FOR MORE THAN 30 DAYS CAN CAUSE INACCURATE READINGS. DARIO'S REPRESENTATIVE OFFERED TO SEND THE USER CONTROL SOLUTION AND A CARTRIDGE OF STRIPS, IN ORDER TO FURTHER INVESTIGATE THIS ISSUE, HOWEVER THE USER REFUSED TO TROUBLESHOOT WITH DARIO'S REPRESENTATIVES, AND WAS ONLY INTERESTED IN A REFUND. THE HIGH BG READINGS MAY HAVE BEEN DUE TO THE USE OF EXPIRED STRIPS. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING HER DARIO METERS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
822237 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD.

Patients

Seq Age Sex Outcome Treatment
1 66 YR Hospitalization