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

Lot Number 2204211

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem Hyperglycemia (1905)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

While on the phone with dario representative, the user stated that the high readings issue occured across different cartridges of dario strips, since she first bought her dario meter.A replacement of dario's strips was sent to the user to to see if that resolves the issue.In addition a replacement of dario's meter was sent to the user together with a return material authorization (rma) package, to further investigate this issue.After the above was received, dario's representative followed up with the user.The user reported that she was still receiving high bg readings, and that the new replacement dario meter has the same lot number as her other dario meter.Due to the above a second replacement of dario's meter was sent to the user together with a return material authorization (rma) package, to further investigate this issue.After the replacement was received, the user reported that this second dario replacement still gave her a high bg reading of 268 mg/dl compared to a bg reading of 108 mg/dl that she received from her non-dario meter, which the user stated matches the bg reading from her doctor.In addition, the user stated that all three dario meters have the same lot number.In addition, another replacement of dario's strips together with control solution was sent to the user to make sure that the dario strips are reading correctly and to ensure proper technique.As of this date, the new cartridge of strips and control solution were not received.As of this date, both rmas were not received.If the old dario meters are received at a later date, a follow up report will be submitted.There is not enough information available regarding the old dario meters and strips to investigate.No resolution is available.

Event Description

On (b)(6) 2024 the user contacted dario to report high blood glucose (bg) readings.The user reported recently receiving a bg reading of 475 mg/dl from her dario meter compared to a bg reading of 107 mg/dl from her non-dario meter.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: 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: 19056947
• MDR Text Key: 340345308
• Report Number: 3010606081-2024-00020
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 2204211
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female