MAUDE Adverse Event Report: TYSON BIORESEARCH INC. EASY TOUCH BLOOD GLUCOSE MONITORING SYSTEM

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2018

Event Type  malfunction  

Event Description

Meter was out of order.There was no report of death, serious injury or mistreatment associated with this event.

• Brand Name: EASY TOUCH BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): TYSON BIORESEARCH INC.; 5f., no. 16, 18, 20, 22,; kedong 3rd rd., zhunan,; miaoli county, taiwan 35053 ; TW 35053
• Manufacturer (Section G): TYSON BIORESEARCH INC.; 5f., no. 16, 18, 20, 22,; kedong 3rd rd., zhunan,; miaoli county, taiwan 35053 ; TW 35053
• Manufacturer Contact: vance chang ; 5f., no. 16, 18, 20, 22,; kedong 3rd rd., zhunan,; miaoli county, taiwan 35053 ; TW 35053
• MDR Report Key: 8276814
• MDR Text Key: 134065251
• Report Number: 3003132490-2019-00005
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K101543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/02/2019,01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1