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	04/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported receiving the low readings while using the last couple of strips left in her cartridge.The user mentioned that her normal bg range is between 89 mg/dl to 116 mg/dl.The user also stated that her strips expired on april 15, 2026.Dario's user guide states in the section factors that may lead to innacurate 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 reported that both the new and old cartridges had the same expiration date, being the 15th of april.Dario's representative instructed the user to discard of the expired strip cartridges.A replacement of dario's strips was sent to the user in order to replace the expire strips and to make sure that the dario strips are reading correctly.The low bg readings may have been due to misuse of the strips.There is not enough information regarding the meter to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On april 12th, the user contacted dario to report low blood glucose (bg) readings.The user reported receiving from her dario meter a low bg reading of 40 mg/dl, which did not align with how she was feeling.Following the above, the user reported that she retested several minutes later and received a bg reading that was in normal range for her.

• 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: 25150815
• Report Number: 3010606081-2026-00035
• Device Sequence Number: 9351878
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): N
• 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): 05/12/2026

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: 1021-06
• 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: 05/12/2026
• 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: 58 YR
• Patient Sex: Female