FDA Adverse Event Malfunction Summary report: N

DARIO BLOOD GLUCOSE MONITORING SYSTEM

MDR report key: 11705594 · Received April 22, 2021

Report

Report Number
3010606081-2021-00008
Event Type
Malfunction
Date Received
April 22, 2021
Date of Event
March 22, 2021
Report Date
April 22, 2021
Manufacturer
LABSTYLE INNOVATIONS LTD.
Product Code
NBW
PMA / PMN Number
K150817
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
WI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON MARCH 22ND, THE USER CONTACTED DARIO TO REPORT INACCURATE BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT SHE RECEIVED READINGS WITH A DIFFERENCE OF UP TO 50 MG/DL WHEN COMPARING HER TWO DARIO METERS. ON MARCH 19TH THE USER RECEIVED A HIGH BG READING. DUE TO THIS ELEVATED READING, SHE OVERMEDICATED WITH INSULIN AND STARTED TO FEEL SHAKY. THE USER THEN MEASURED HER BG LEVELS AND RECEIVED A READING OF 58 MG/DL. THE USER REPORTED THAT SHE DID NOT GO TO THE HOSPITAL OR TALK TO HER DOCTOR. THE USER REPORTED THAT SHE ATE AND THEN HER BG LEVELS STABILIZED. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVES, THE USER TESTED AND REPORTED RECEIVING A BG READING OF 151 MG/DL FROM HER FIRST DARIO METER COMPARED TO 180 MG/DL FROM HER OTHER DARIO METER. A REPLACEMENT OF DARIO'S METER, CARTRIDGE OF STRIPS, AND CONTROL SOLUTION WERE SENT TO THE USER TO FURTHER INVESTIGATE THIS ISSUE. WHILE FOLLOWING UP WITH THE USER, THE USER REPORTED THAT SHE HAD THROWN AWAY THE TWO METERS THAT SHE BELIEVED TO BE GIVING HER INACCURATE READINGS, AND THEREFORE COULD NOT RETURN THEM FOR FURTHER INVESTIGATION. SHE REPORTED THAT SHE HAD A TOTAL OF FOUR DARIO METERS; TWO THAT SHE THREW AWAY, AND TWO THAT ARE READING ACCURATELY. THE USER REPORTED THAT SHE TESTED THE TWO METERS THAT SHE KEPT WITH NEW STRIPS AND CONTROL SOLUTION THAT SHE RECEIVED, AND HER READINGS WERE IN RANGE. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING HER TWO OTHER METERS AND STRIPS TO FURTHER INVESTIGATE THIS CASE, AS THE USER THREW THEM AWAY. THEREFORE, NO RESOLUTION IS AVAILABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
602335 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD.

Patients

Seq Age Sex Outcome Treatment
1 55 YR Other