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	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported receiving from her dario meter a fasting bg reading of 150 mg/dl.The user reported that due to the above, she performed a control solution test, where she received a bg reading of 178 mg/dl for level 1 and a bg reading of 369 mg/dl for level 2, both which were out of range, according to the user.The user stated that she did not have her device with her at the time of the troubleshooting, and therefore could not troubleshoot at that time.Multiple attempts to follow up with the user were made, however, no response has been received to date.There is not enough information 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 stated that her dario meter is not reading her bg level correctly.

• 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: 22134153
• Report Number: 3010606081-2025-00027
• Device Sequence Number: 7314955
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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): 06/03/2025

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
• 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: 06/03/2025
• 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 Age: 56 YR
• Patient Sex: Female