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

Model Number	1021-04
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6), the user left a voicemail stating that she received from her dario meter a difference of 20 mg/dl to 30 mg/dl in her bg readings, when testing consecutively.At a later date, during troubleshooting on the phone with dario's representative, the user reported receiving a bg reading of 120 mg/dl from her dario meter, followed by a bg reading of 160 mg/dl with a different drop of blood.During the troubleshooting above, it was determined that the user was storing her cartridge of strips in the bathroom.Dario's user guide states in the section of general precautions: "do not store the meter or test strips in an area where the humidity is outside of the range 10-90%, such as a bathroom or kitchen." after the above, dario's representative instructed the user to open a new cartridge of strips and test her bg level, however since the user's phone was at a very low battery percentage, the user stated that she would first sufficiently charge her phone, and then test her bg using the same drop of blood, and will email dario the results.An hour later, the user emailed dario her bg readings with the new catridge of strips, receiving bg readings of 111 mg/dl and 112 mg/dl consecutively.Dario's representative reminded the user to store the strips cartridge in a room that is not humid.Later that day, the user tested her bg again with the dario meter and received bg readings of 122 mg/dl, 128 mg/dl, and 131 mg/dl within a period of two minutes.Since the user's bg reading issue was resolved with new strips, therefore, it can be determined that there was misuse of the strips.This complaint is not confirmed.
Event or Problem Description
On (b)(6), the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported receiving from her dario meter five completely different readings when testing her bg five times in a row.

• 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: 23037529
• Report Number: 3010606081-2025-00070
• Device Sequence Number: 9207885
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 09/12/2025

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: 09/12/2025
• 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: 74 YR
• Patient Sex: Female