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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN YOWOW BIT FITNESS ACTIVITY MONITOR HEALTH TRACKER WATCH; INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
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UNKNOWN YOWOW BIT FITNESS ACTIVITY MONITOR HEALTH TRACKER WATCH; INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY Back to Search Results
Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2024
Event Type  malfunction  
Event Description
Last year i bought a yowow smart watch, which claims to measure blood glucose, however it does not have any way to pierce the skin, it has just the leds on the back.I have been suspicious of its readings for quite some time and was glad to see your recently issued warning that this type of device should not be relied upon.This device gives very consistently identical glucose readings all the time no matter how much i may vary my food intake or times of eating.Therefore my suspicion.I do not take insulin or anything, so there was no harm done.I was just trying to keep an eye on my blood glucose.If you have any questions feel free to contact me.Reference report: mw5152228.
 
Event Description
Additional information received on 15-mar-2024, for mw5152229.Correcting procode information.
 
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Brand Name
YOWOW BIT FITNESS ACTIVITY MONITOR HEALTH TRACKER WATCH
Type of Device
INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
Manufacturer (Section D)
UNKNOWN
MDR Report Key18816691
MDR Text Key336822395
Report NumberMW5152229
Device Sequence Number1
Product Code NCT
Combination Product (y/n)N
Number of Events Reported1
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 Received02/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Patient Sequence Number1
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