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); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On january 9th, the user contacted dario to report inconsistent and high blood glucose (bg) readings.The user reported that the bg readings that she received from her dario meter when compared to her non-dario meter are not aligned.
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported that she has an older dario meter which she also uses to test her bg, and is also giving her high bg readings.The user also added that she has been receiving bg readings of 107 mg/dl in the mornings and now she is receiving 254 mg/dl.Due to the above, the user opened a new cartridge of strips, however the user reported that the new strips were also giving her high bg readings of 101 mg/dl, 113 mg/dl and 147 mg/dl.The user reported that she tested using new control solution with a new package of strips, and received bg readings of 269 mg/dl and 237 mg/dl.The user added that she retested using the control solution under fasting conditions using a non-dario meter and received a bg reading of 230 mg/dl.The user, when speaking with dario's representative, also mentioned that the control solution that she used was expired.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.This case is still in progress, since the user has not yet received the replacement of the dario strips and control solution.If new information is received at a later date, a follow up report will be submitted.There is not enough information available regarding the dario meters and strips to investigate.No resolution is available.
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported that she has an older dario meter which she also uses to test her bg, and is also giving her high bg readings.The user also added that she has been receiving bg readings of 107 mg/dl in the mornings and now she is receiving 254 mg/dl.Due to the above, the user opened a new cartridge of strips, however the user reported that the new strips were also giving her high bg readings of 101 mg/dl, 113 mg/dl and 147 mg/dl.The user reported that she tested using new control solution with a new package of strips, and received bg readings of 269 mg/dl and 237 mg/dl.The user added that she retested using the control solution under fasting conditions using a non-dario meter and received a bg reading of 230 mg/dl.The user, when speaking with dario's representative, also mentioned that the control solution that she used was expired.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.This case is still in progress, since the user has not yet received the replacement of the dario strips and control solution.If new information is received at a later date, a follow up report will be submitted.There is not enough information available regarding the dario meters and strips to investigate.No resolution is available.Addition for the follow-up report: on the 20th of february, the user contacted dario to report that after receiving the replacement of dario's strips and control solution, she used them to test her dario meter and new test strips, which the user reported are now working as expected.There is not enough information available regarding the old dario meters and strips to investigate.No resolution is available.
Event or Problem Description
On january 9th, the user contacted dario to report inconsistent and high blood glucose (bg) readings.The user reported that the bg readings that she received from her dario meter when compared to her non-dario meter are not aligned.

• 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: 24290474
• Report Number: 3010606081-2026-00002
• Device Sequence Number: 13120556
• Product Code: NBW
• UDI-Device Identifier: 00850065006758
• UDI-Public: 850065006758
• 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,Followup
• Report Date (Section B): 02/26/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/26/2026
• 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: 77 YR
• Patient Sex: Female