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 Problem Hyperglycemia (1905)

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

As the user reported that he was out of new test strips to measure with, a replacement of dario's strips and control solution were sent to the user to further investigate this issue.In a follow-up phone call to the user, the user stated that she tested her bg level with the new cartridge of strips and the readings were within range.Therefore, the high bg readings are not due to a meter issue.There is not enough information regarding the old strips to investigate.Therefore, no resolution is available.

Event Description

On (b)(6), the user contacted dario to report high blood glucose (bg) readings.The user reported that from the 2nd to the 5th of november he tested his bg level using the dario meter which gave him readings of: 424 mg/dl, 431 mg/dl, 433 mg/dl, 460 mg/dl, 468 mg/dl, and 487 mg/dl.Due to these high readings, on (b)(6), the user went to the urgent care and the hospital where his bg level was tested with the hospital's meter and was found to read 140 mg/dl.

• 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; new york, NY 10011 ; 3106251600
• MDR Report Key: 15986180
• MDR Text Key: 305497896
• Report Number: 3010606081-2022-00032
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• 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: 12/15/2022

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: 12/15/2022
• 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): Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male