BLE Smart® Test Strips BLE-TS50-FDARecalls & reported problems
Entra Health Systems LLC · Glucose Test Strips · 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 00850081003960), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
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.
Most reported problems
Device problems
- High Test Results1
- Nonstandard Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2019High Test Results; Nonstandard Device; High Test Results
MEDWATCH REPORT NUMBER MW5090833 WAS REPORTED TO ENTRA HEALTH ON NOVEMBER 14 2019. COMPLAINANT INFORMED ENTRA HEALTH SYSTEMS ON NOVEMBER 4 2019 OF AN ISSUE STATING THAT THE BLE SMART FROM LOT B18J19-5B1 WAS GIVING HIGHER THAN NORMAL READINGS WHEN COMPARING METER READINGS AGAINST THE FREESTYLE LITE METER. IN ADDITION, THE COMPLAINANT STATED THE METER WAS GIVING READINGS OUT OF THE ACCEPTABLE RANGE OF 0-20% ERROR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9406931 ↗
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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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