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

Model Number 1021-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/30/2018

Event Type  Death  

Event Description

On (b)(6) 2018, the customer (b)(6) wife called to report that her husband passed away.She said that they are not sure if the death is related to his diabetes.The death is not related to the use of the darion meter device.

• 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: tracey wielinski ; 5 casie lane; pepperell, MA 01463 ; 4409155833
• MDR Report Key: 8193108
• MDR Text Key: 131297793
• Report Number: 3010606081-2018-00022
• 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: 12/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 1021-04
• Device Lot Number: 1805021
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR