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	07/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After multiple attempts to follow up with the user, dario spoke to the user on the phone, and it was determined that the user was using a cartridge of strips that were expired.Dario's user guide states in the section factors that may lead to inaccurate results: "the test strip is expired." and in the test strip precautions section: "check the "use by" date on the test strip cartridge.Do not use the test strips after that date".The user stated that he was not interested in purchasing new strip cartridges at that time, and therefore further troubleshooting could not be performed.The high bg readings may have been due to misuse of the strips.There is not enough information regarding the meter available to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On july 21st, the user contacted dario to report high blood glucose (bg) readings.The user reported that on the night previous to contacting dario, he tested his bg using his wireless sensor device, and received readings between 54 mg/dl and approximately 100 mg/dl at different times.The user also reported that in comparison, he received bg readings of 284 mg/dl, 286 mg/dl, and 287 mg/dl from his dario 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: 22831431
• Report Number: 3010606081-2025-00055
• Device Sequence Number: 14596847
• Product Code: NBW
• UDI-Device Identifier: 00850065006741
• UDI-Public: 850065006741
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: 61 YR
• Patient Sex: Male