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

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

Patient Problems Hyperglycemia (1905); Insufficient Information (4580)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

While on the phone with dario's representative, it was determined that the user was using a cartridge of strips that were open for more than a month and was therefore expired.Dario's user guide states in the section precautions: "do not use a test strip expired 1 month from opening.Discard the cartridge 1 month after opening." the user also reported that he stores his cartridges of strips in the kitchen.Dario's user guide states in the section regarding "causes of unexpected results", that the storage of strips in places with high humidity, such as the kitchen can cause unexpected results.A replacement of dario's control solution was sent to the user to further investigate this issue.Once received by the user, dario's representative followed up with the user and did a control solution test with a new cartridge of strips.The strips were reading within range, however the user stated that these bg readings were still different than the readings that he received at the doctor's office.Due to the difference in the readings described above, a replacement of dario's meter was sent to the user to further investigate this issue.Multiple attempts were made to follow up with the user, in order to test the replacement meter, however, no response has been received to date.The high bg readings may have been due to the misuse of strips.There is not enough information regarding the old strips and meter to investigate.No resolution is available.

Event Description

On (b)(6), the user, who lives in australia, contacted dario to report high blood glucose (bg) readings.The user reported that he received from his dario meter high bg readings ever since receiving the device.Due to these high readings, the user went to his doctor where his bg level was measured with the doctor's meter which read 8.2 mmol compared to a bg reading of 15.6 mmol from the user's dario meter.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: NBW
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: rick anderson ; 18 w. 18th street; 5th floor; new york, NY 10011 ; 3106251600
• MDR Report Key: 15866940
• MDR Text Key: 307771068
• Report Number: 3010606081-2022-00029
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 11/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Sex: Male