FDA Device Intelligence
HomeDevice types › PQF

Sensor, Glucose, Invasive, Non-Adjunctive

FDA product code PQF · Class 3 · Unknown

17
Registered devices
324,701
Adverse events
4
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-05-24Tandem Diabetes Care IncInsulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On,
2022-05-24Tandem Diabetes Care IncInsulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On,
2020-09-10Tandem Diabetes Care IncInsulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the batte
2020-02-03Dexcom IncThe company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous G

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.