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	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following multiple attempts to reach the user, the user contacted dario on may 7th, stating that he had received our email.The user reported that since his two previous cartridges expired on the 15th of may, he discarded them.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 also stated that he recently received a shipment of new test strips, and is testing his bg with these new test strips.Dario's representatives attempted to contact the user in order to confirm that the user is now receiving bg readings that are in range for the user, however no response has been received to date.The inconsistent bg readings may have been due to misuse of the strips.There is not enough information available to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On april 13th, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported receiving from his dario meter a bg reading of 159 mg/dl from one test strip cartridge compared to a bg reading of 128 mg/dl from a different test strip cartridge.The user reported that both cartridges had the same lot number and expiration date, being the 15th of april.The user also reported that he tested his bg several times using both test strip cartridges, and each time he received a 30 mg/dl difference in bg readings between the two cartridges.

• 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: 25158286
• Report Number: 3010606081-2026-00037
• Device Sequence Number: 18486283
• Product Code: NBW
• UDI-Device Identifier: 00850065006253
• UDI-Public: 850065006253
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 05/13/2026

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: 05/13/2026
• 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: 67 YR
• Patient Sex: Male