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Simplera™ Sensor

MEDTRONIC MINIMED, INC. · Model MMT-5100JA · UDI-DI 20763000565026

PQF Prescription
0
510(k) clearances
327,318
Adverse events (10 deaths)
4
Recalls
5
Facilities

Description

SENSOR MMT-5100JA SIMPLERA 5PK US

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, 4) Unexpected Open L
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, 4) Unexpected Open L
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 battery life drops to les
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 Glucose Monitoring Sy

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.