MAUDE Adverse Event Report: KOALARHEALTH KHA1 AMOLED BUSINESS HEALTH SMARTWATCH BLOOD GLUCOSE MONITORING; INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY

Model Number KHA1

Device Problem High Readings (2459)

Patient Problem Hypoglycemia (1912)

Event Date 01/15/2024

Event Type  malfunction  

Event Description

I bought a koalarhealth smartwatch online, it is advertised as a glucose monitor, b/p (blood pressure) monitor, ekg (electrocardiogram) monitor, radiation monitor, uric acid monitor, lipid panel monitoring.I had doubts initially, but thought that since it was less than (b)(6) (dollars), that i wouldn't be out too much money, also i was planning on verifying with my traditional bs (blood sugar) monitor and b/p (blood pressure) monitor.For the first month, there was little difference.However, after 2.5 months of wear, the watch started giving me abnormally high results for a couple of days then go back down (again results were consistent with traditional monitoring for a month) then again i started getting abnormal high results and my traditional monitor was still reading "normal" results.Hoping that the watch would "go back to normal" i continued to wear it.But no, the bs (blood sugar) and b/p (blood pressure) values remained high.Thinking that there was very little inconsistencies with the traditional monitors, i reported the watches values higher values to my doctor, who in turn prescribed me medication (that ended up dropping my bs (blood sugar) to a dangerously low value).Koalarhealth blood sugar reading 375, while my traditional monitor said 103.Reference report: mw5152224.

Event Description

Additional information received on 15-mar-2024, for mw5152225.Correcting procode information.

• Brand Name: KHA1 AMOLED BUSINESS HEALTH SMARTWATCH BLOOD GLUCOSE MONITORING
• Type of Device: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
• Manufacturer (Section D): KOALARHEALTH
• MDR Report Key: 18816557
• MDR Text Key: 336800976
• Report Number: MW5152225
• 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: 02/21/2024
• 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: KHA1
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BLOOD GLUCOSE METER.
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Hispanic
• Patient Race: White