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

Model Number	1021-04
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported that she received a bg reading of 225 mg/dl from her dario meter compared to a bg reading of 111 mg/dl from her non-dario meter.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, multiple attempts to follow up with the user were made, however, no response has been received to date.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 (b)(6), the user contacted dario to report high blood glucose (bg) readings.The user reported receiving from her dario meter bg readings ranging from 100 mg/dl to 220 mg/dl within a 24 hour period.In addition, the user reported that she continues to receive bg readings that are over 200 mg/dl.The user stated that until this issue occured, the user had never received a bg reading above 120 mg/dl.Due to the above, the user purchased a non-dario meter, which she tested with and received a bg reading of 99 mg/dl.
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported that she received a bg reading of 225 mg/dl from her dario meter compared to a bg reading of 111 mg/dl from her non-dario meter.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, multiple attempts to follow up with the user were made, however, no response has been received to date.There is not enough information regarding the meter and old strips available to further investigate this case.Therefore, no resolution is available.Additional information: on september 17th, the user contacted dario to report that her issue was resolved with the new cartridge of 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 august 26th, the user contacted dario to report high blood glucose (bg) readings.The user reported receiving from her dario meter bg readings ranging from 100 mg/dl to 220 mg/dl within a 24 hour period.In addition, the user reported that she continues to received bg readings that are over 200 mg/dl.The user stated that until this issue occured, the user had never received a bg reading above 120 mg/dl.Due to the above, the user purchased a non-dario meter, which she tested with and received a bg reading of 99 mg/dl.

• 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: 23072389
• Report Number: 3010606081-2025-00074
• Device Sequence Number: 21285200
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/04/2025

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: 1021-04
• Device Lot Number: 2104301
• 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: 09/17/2025
• Supplement Report FDA Received Date: 11/04/2025
• 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