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	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported receiving from her dario meter a bg reading of 130 mg/dl compared to a bg reading of 144 mg/dl from her non-dario meter.The user told dario's representative that this issue has persisted for over a year with different lot numbers.Dario's representative instructed the user to open a new cartridge of strips and test her bg level, which she did and received a bg reading of 186 mg/dl from her dario meter compared to a bg reading of 251 mg/dl from her non-dario meter.Due to the above, a replacement of dario's strips and control solution was sent to the user to make sure that the dario strips are reading correctly, and to ensure proper technique.After the above was received, an attempt to follow up with the user was made, however, no response has been received to date.There is not enough information regarding the dario strips and dario meter to investigate.No resolution is available.
Event or Problem Description
On february 16th, the user contacted dario to report low blood glucose (bg) readings.The user reported receiving an ea1c of 6.9% from her dario meter compared to an a1c of 8.3% from her doctor's bg meter.Due to this difference the user reported that she had stopped using the dario meter for some time.In addition, the user reported receiving a bg reading of 133 mg/dl from her dario meter compared to a bg reading of 157 mg/dl from her non-dario meter.The user stated that when she began using the dario meter, her bg readings were only slightly different than her non-dario meter, such as an ea1c of 7.4% from her dario meter, compared to an a1c of 7.8% from her non-dario 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: 24601652
• Report Number: 3010606081-2026-00017
• Device Sequence Number: 9507651
• Product Code: NBW
• UDI-Device Identifier: 00850065006406
• UDI-Public: 850065006406
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/15/2026

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: 03/15/2026
• 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 Sex: Female