MAUDE Adverse Event Report: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD CARETOUCH; BLOOD PRESSURE MONITOR

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer complaint - limited data available.Customer complained that they had received inaccurate readings while using the device.
Event or Problem Description
Customer complaint - limited data available customer review complaint: would not recommend the readings are way off.When using this monitor my blood pressure shows 85 - 93/ 53 - 58.When the results are in this range i check it with another monitor.The results are more accurate showing my blood pressure to be 115 - 120/ 70 - 75.The best feature it is easy to use.I missed the deadline to return or it would be going back to amazon.

• Brand Name: CARETOUCH
• Common Device Name: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD; zone a, no.105, dongli road; torch development district, zh; zhongshan, guangdong ; CH
• MDR Report Key: 16871682
• Report Number: 3016774562-2023-01000
• Device Sequence Number: 5461692
• Product Code: DXN
• 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,Followup
• Report Date (Section B): 05/04/2023
• Report Date (Section F): 05/04/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/20/2023
• Date Report to Manufacturer: 04/25/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 01/16/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/04/2023