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	07/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts to follow up with the user were made, however the user could not be reached.The user did, however, respond by email several times to state that she was traveling and did not receive dario's messages.In addition, the user stated that she was interested in returning the dario meter.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 that she purchased a dario meter for her niece, who received bg readings of over 400 mg/dl.Due to the above, the user's niece went to the doctor, where her bg was tested with the doctor's meter and read 109 mg/dl.The user also reported that since her niece received a device from her doctor, she tests side-by-side with this meter and her dario meter, using the same drop of blood, and that the dario meter is still giving a high bg for the user's niece.

• 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: 22829400
• Report Number: 3010606081-2025-00054
• Device Sequence Number: 4553504
• Product Code: NBW
• UDI-Device Identifier: 00850065006758
• UDI-Public: 850065006758
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 08/18/2025

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: 1021-06
• 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: 08/18/2025
• 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: 72 YR
• Patient Sex: Female