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); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), the user contacted dario to report low blood glucose (bg) readings.The user, who recently received his dario meter, reported receiving a bg reading of 130 mg/dl with the dario meter compared to a bg reading of 178 from his non-dario meter.The user stated that after cleaning with alcohol, he received a bg reading of 144 mg/dl from his dario meter compared to a bg reading of 179 mg/dl from his non-dario meter.
Additional Manufacturer Narrative
While on the phone with the user when he first contacted dario, dario's representative informed the user that a replacement of dario's strips would be sent to him.The user stated that he had used alcohol before testing his bg.Dario's user guide states in the section of factors that interfere with blood glucose testing: "alcohol can affect test results." on august 12th, dario's representative followed up with the user in order to test with the new strips cartridge.The user stated that he is testing using his dario meter and two additional devices, which give him different bg readings.The user reported receiving one day prior, a bg reading of 154 mg/dl from his dario meter, compared to bg readings of 166 mg/dl and 169 mg/dl from his other non-dario meters.The user also stated that on (b)(6), he received a bg reading of 129 mg/dl from his dario meter, compared to bg readings of 145 mg/dl and 162 mg/dl from his non-dario meters.During this troubleshooting, it was determined that the user was storing his strips on the kitchen table.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." the user was informed regarding proper test storage conditions.The low bg readings may have been due to user misuse.There is not enough information regarding the meter and old strips available to further investigate this case.Therefore, no resolution is available.

• 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: 22833474
• Report Number: 3010606081-2025-00056
• Device Sequence Number: 21196803
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): Y
• 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): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 73 YR
• Patient Sex: Male