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

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user stated that he was not at home and was unable to 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 inconsistent blood glucose (bg) readings.The user reported receiving bg readings from his dario meter that do not match the bg readings that he received from his non-dario meter.Furthermore, the user reported that the bg readings from his non-dario meter match the readings compared to his patient care management (pcm) system's 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: 21988162
• Report Number: 3010606081-2025-00022
• Device Sequence Number: 4311341
• Product Code: NBW
• UDI-Device Identifier: 00850065006406
• UDI-Public: 850065006406
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/08/2025

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
• 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: 05/08/2025
• 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: Male