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	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, it was determined that the user was storing all of his test strips in a plastic bag instead of inside the strips cartridge.Dario's user guide states in the section storage and handling precautions: "a test strip is sensitive to humidity.Therefore, you should keep a test strip in the specified cartridge, and after pulling out the test strip from its cartridge, close the test strip cartridge cap immediately." it was also determined that the user was using a cartridge of test strips that had been open for forty-five days.Dario's user guide states in the section storage and handling precautions: "do not use a test strip expired 1 month from opening.Discard the cartridge 1 month after opening".Due to the above, a replacement of dario's strips and control solution was sent to the user to make sure that the dario strips are reading correctly, and to ensure proper technique.After the above was received, multiple attempts to follow up with the user were made, however, no response has been received to date.The high bg readings may have been due to misuse of the strips.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 receiving bg readings in the 500 mg/dl range from his dario meter compared to bg readings in the 100 mg/dl to 110 mg/dl range from the user's other non-dario meters.

• 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: 22992013
• Report Number: 3010606081-2025-00064
• Device Sequence Number: 9089795
• Product Code: NBW
• UDI-Device Identifier: 00850065006741
• UDI-Public: 850065006741
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 09/08/2025

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
• Device Model Number: 1021-06
• Device Lot Number: 2403041
• 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: 09/08/2025
• 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 Age: 55 YR
• Patient Sex: Male