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

Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported receiving bg readings in the range of 140 mg/dl to 150 mg/dl from her dario meter.The user then reported that she went to a doctor's appointment and was told by her doctor that her a1c was high and therefore, her bg reading should be above 200 mg/dl.The user then stated that after purchasing a new cartridge of strips, she tested her bg level and still received bg readings in the 140 mg/dl to 150 mg/dl range.The user had another a1c lab test performed, which came out to be 7.5%, which the doctor stated should present as a bg range of 170 mg/dl to 190 mg/dl.The user mentioned that she bases her breakfast according to her fasting bg levels.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, an attempt to follow up with the user were made, however, no response has been received to date.There is not enough information available to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On september 8th, the user contacted dario to report low blood glucose (bg) readings.The user stated that for the past couple of years, she has been receiving bg readings that were 30 mg/dl to 50 mg/dl lower than her actual bg readings from her a1c.

• 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: 20401936
• Report Number: 3010606081-2024-00061
• Device Sequence Number: 19706196
• Product Code: NBW
• UDI-Device Identifier: 00850065006161
• UDI-Public: 850065006161
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/08/2024

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
• 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: 10/08/2024
• 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 Sex: Female