MAUDE Adverse Event Report: LABSTYLE INNOVATIONS LTD. DARIO BLOOD GLUCOSE MONITORING SYSTEM; NBW

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problems Hypoglycemia (1912); Hot Flashes/Flushes (2153)

Event Date 12/17/2020

Event Type  malfunction  

Event Description

On december 17th, 2020, the user contacted dario to report elevated blood glucose (bg) readings.Prior to contacting dario, the user reported receiving a high bg reading of 235 mg/dl compared with a non-dario meter which measured 173 mg/dl.After several minutes, the user tested once again with the dario meter and received a reading of 190 mg/dl.The user reported that he has been insulin dependent for the past 10 years.The user reported that several times he woke up in the middle of the night feeling sweaty, so he tested his bg level and found it to be in the 60s mg/dl range.When this happened, the user ate something in order to elevate his bg level.The user did not report seeking any further medical intervention due to the above readings.Dario's representative instructed the user to open a new strips cartridge and test his bg level.The user tested and received a fasting bg reading of 159 mg/dl, and after eating breakfast a bg reading of 228 mg/dl.While on the phone with dario's representative, the user reported that he stores his strips cartridge in the kitchen.Dario's user guide states in the section regarding 'general precautions' "do not store the meter or test strips in an area where the humidity is outside of the range 10-90%, such as a bathroom or kitchen", and in the section of 'causes of unexpected results' it is asked "were the test strips stored in areas of high humidity such as the kitchen or the bathroom?" the user also reported that he keeps a meter in the car.Dario's user guide states in the section general precautions: do not leave the meter in very hot or cold places.Do not leave it near a heat source (radiator) or in a car in hot or cold weather.The user also reported to dario's representative that he changes his lancets only once every 2 weeks.Dario's user guide also states in the warning section: use lancets only once.Dario's control solution was sent to the user to further investigate the accuracy of the meter and strips.Multiple attempts to follow up with the user were made, however, no response has been received to date.The above described events, indicate misuse of strips.There is not enough information available to further investigate this case.Therefore, no resolution is available.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: NBW
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: rick anderson ; 142 w. 57th street; 8th floor; new york, NY 10019 ; 3106251600
• MDR Report Key: 11162437
• MDR Text Key: 261252149
• Report Number: 3010606081-2020-00036
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other