T:SLIM G4 SYSTEM 4628-003 008114

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-29 for T:SLIM G4 SYSTEM 4628-003 008114 manufactured by Tandem Diabetes Care.

MAUDE Entry Details

Report Number3013756811-2019-84897
MDR Report Key9391864
Report SourceCONSUMER
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-16
Date Mfgr Received2019-11-16
Device Manufacturer Date2017-06-01
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICK TRIER
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8584011451
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameT:SLIM G4 SYSTEM
Generic NameINSULIN PUMP
Product CodeOYC
Date Received2019-11-29
Returned To Mfg2019-11-26
Model Number4628-003
Catalog Number008114
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTANDEM DIABETES CARE
Manufacturer Address11075 ROSELLE STREET SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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