MAUDE Adverse Event Report: LABSTYLE INNOVATIONS LTD. DARIO BLOOD GLUCOSE MONITORING SYSTEM; GLUCOMETER

Model Number	1021-04
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user stated that his a1c at his doctor's office, six months prior, was 6.5%, while at the user's last visit to the doctor, he received an a1c of 7.9%.The user also stated that his dario meter shows a low ea1c consistent with his low bg readings.While on the phone with dario's representative, it was determined that the user was storing his strips cartridge in the bathroom.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." 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 may 13th, the user contacted dario to report low blood glucose (bg) readings.The user reported receiving lower bg readings and ea1c from his dario meter when compared to the results that he received from his veteran affairs (va) medical facility.The user stated that for the past several months, he received from his dario meter an ea1c of less than 7%, and is currently 5.7%.This result is compared to the a1c of 7.9% that the user received from his va medical facility on may 9th.In addition, the user stated that the ea1c that he received from his dario meter has been significantly lower than 7% for at least ninety days.The user also reported that on may 9th, he received bg readings of 100 mg/dl and 104 mg/dl from his dario meter compared to a bg reading of 146 mg/dl that he received fom his va medical facility, both readings being taken thirty minutes apart.

• 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: 22196126
• Report Number: 3010606081-2025-00030
• Device Sequence Number: 9275030
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/12/2025

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: 1021-04
• 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: 06/12/2025
• 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: 80 YR
• Patient Sex: Male