FDA Adverse Event
Malfunction
Summary report: N
BG5 SMART / IHEALTHLAB
MDR report key: 9028299
·
Received September 12, 2019
Report
- Report Number
- MW5089763
- Event Type
- Malfunction
- Date Received
- September 12, 2019
- Date of Event
- September 6, 2019
- Report Date
- September 10, 2019
- Manufacturer
- ANDON HEALTH CO. LTD.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IHEALTH BG5 SMART GLUCOSE TESTING DEVICE, CONTINUOUSLY REPORTS EXTREMELY HIGH RESULTS WHICH ARE NOT BEING CONSISTENT WITH A1C RESULTS. IT IS SUCH A PROBLEM THAT I ALWAYS TEST WITH TWO (2) DIFFERENT METERS, IHEALTH BG5 SMART AND ONE TOUCH VERIO FLEX. I HAVE REPLACED AND UPDATED BOTH DEVICES, REPLACED TEST STRIPS. IHEALTH SUPPORT OVER THE LAST TWO YEARS AND THE IHEALTH SMART METER RESULTS ARE ALWAYS 20 TO 50 POINTS HIGHER THAN ANY OTHER TESTING DEVICE RESULTS. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798739 | BG5 SMART / IHEALTHLAB | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | NBW | ANDON HEALTH CO. LTD. | BG5122D54 | ||
| 798740 | BG5 SMART / IHEALTHLAB | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | NBW | ANDON HEALTH CO. LTD. | BG5122D54 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |