MAUDE Adverse Event Report: SHEN ZHEN BALE ELECTRONICS CO.,LTD HEALTH SMART WATCH; INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY

Model Number EP03

Device Problems Product Quality Problem (1506); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

Bought smart watch that said measures blood glucose levels.It's totally doesn't.It has predetermined blood glucose cycle, have no effect on what and when you eat.Reference report: mw5152226.

Event Description

Additional information received on 15-mar-2024, for mw5152227.Correcting procode information.

• Brand Name: HEALTH SMART WATCH
• Type of Device: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
• Manufacturer (Section D): SHEN ZHEN BALE ELECTRONICS CO.,LTD; wanzhongcheng clothing wholesale market xinniu community, minzhi street; room b335; longhua district, shenzhen ; CH
• MDR Report Key: 18816611
• MDR Text Key: 336822080
• Report Number: MW5152227
• Device Sequence Number: 1
• Product Code: NCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EP03
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LIPITOR.; METFORMIN.; ONE A DAY VITAMINS.; VALSARTAN.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian