MAUDE Adverse Event Report: EPS BIO TECHNOLOGY CORP. M2_MG; GLUCOSE MONITORING SYSTEM

Model Number 100702137

Device Problem Measurement System Incompatibility (2982)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Event Description

No response after strip insertion, total four devices.

• Brand Name: M2_MG
• Type of Device: GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): EPS BIO TECHNOLOGY CORP.; no.8 r&d rd.iii; hsinchu science park; hsinchu, 30076 ; TW 30076
• Manufacturer (Section G): EPS BIO TECHNOLOGY CORP.; no.8 r&d rd.iii; hsinchu science park; hsinchu, 30076 ; TW 30076
• Manufacturer Contact: iden chen ; no.8 r&d rd.iii; hsinchu science park; hsinchu, 30076 ; TW 30076
• MDR Report Key: 9881872
• MDR Text Key: 193432674
• Report Number: 3004130086-2020-00007
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K190189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100702137
• Device Catalogue Number: 100702137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1