MAUDE Adverse Event Report: TIANJIN EMPECS MEDICAL DEVICE CO., LTD. CARETOUCH; BLOOD GLUCOSE TEST SYSTEM

Model Number	CT210
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer complaint: after few round of testing, looks like the kits having accuracy issue, see attached photo, 2 blood tests from same finger, within a minute, showing 93mg/dl and 115mg/dl.

• Brand Name: CARETOUCH
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): TIANJIN EMPECS MEDICAL DEVICE CO., LTD.; no. 35 and 37, yingcheng stree; hangu binhai new area; tianjin, 30048 0; CH 300480
• MDR Report Key: 16491856
• Report Number: 3016774562-2023-00615
• Device Sequence Number: 6759048
• Product Code: NBW
• UDI-Device Identifier: 00370393210202
• UDI-Public: 00370393210202
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2023
• Report Date (Section F): 02/28/2023

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?: No
• Device Model Number: CT210
• Device Catalogue Number: B076VSN7TR
• Distributor Facility Aware Date: 02/10/2023
• Date Report to Manufacturer: 02/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown