AUVON DS-W5050011Recalls & reported problems
Shenzhen Yuwen E-Commerce Co., Ltd. · The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06971292001324), received between Jan 2, 2025 and Jan 2, 2025 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- Hypoglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE CUSTOMER BOUGHT AN AUVON GLUCOSE MONITORING SYSTEM BECAUSE HER PRACTITIONER WAS CONCERNED SHE MIGHT BE BEHAVING HYPOGLYCEMIC EVENTS. SHE DID A SERIES OF 3 DEXCOM CGM'S AND ONE CGM HAD ERRATIC RESULTS SO SHE BOUGHT THE AUVON KIT ONLINE TO VERIFY AND RECALIBRATE THE CGM.BUT, HER VALUES ON THE AUVON WERE CONSISTENTLY 20-40MG/DL OVER THE NUMBERS SHOWN ON THE CGM. SHE WOULD PRICK MULTIPLE FINGERS USING NEW STICKS AND LANCETS AND WOULD GET A WIDE RANGE OF NUMBERS (OVER 40DL/ML) OVER 2 MINUTES. ON ADVICE OF OTHER DIABETIC BROTHER, SHE PURCHASED A FREESTYLE BLOOD GLUCOSE MACHINE AND IT CORRELATED STATISTICALLY TO THE CGM EVERY TIME. HER NUMBERS ARE USUALLY 85-115, AND THE AUVON UNIT OFTEN HAD HER NUMBERS BETWEEN 122 AND 140 OVER MANY STICKS AND SITUATIONS. SHE JUST STARTED HER LAST CGM YESTERDAY. TODAY THE CGM SAID 102, FREESTYLE 96, AND AUVON SAYS 138. SHE HOPE US INVESTIGATE THINGS LIKE THIS.
Patient problems: Hypoglycemia
MAUDE report 21064168 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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