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

Model Number	1021-06
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported receiving a bg reading of 94 mg/dl from her dario meter in the morning compared to a bg reading of 108 mg/dl from her non-dario meter.The user also stated that the readings between the two meters are sometimes similar.While on the phone with dario's representative, it was determined that the user was storing her cartridge of strips in the kitchen.Dario's user guide states in the section of 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." due to the above, a replacement of dario's strips was sent to the user to make sure that the dario strips are reading correctly.This case is still in progress.If additional information is obtained, a follow-up report will be submitted.The low bg readings may have been due to misuse of the strips.There is not enough information regarding the meter and old strips available to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On april 3rd, the user contacted dario to report low blood glucose (bg) readings.The user reported receiving a low bg reading of 87 mg/dl on her dario meter when compared to a bg reading of 123 mg/dl on her old meter.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: GLUCOMETER
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD; 5 tarshish st; north industrial park; caesarea, 30798 21; IS 3079821
• Manufacturer Contact: 5 tarshish st; north industrial park; caesarea, 30798-21
• MDR Report Key: 25063105
• Report Number: 3010606081-2026-00032
• Device Sequence Number: 21367457
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1021-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female