T:SLIM G5 SYSTEM 1000096 1000911

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 2020-03-31 for T:SLIM G5 SYSTEM 1000096 1000911 manufactured by Tandem Diabetes Care.

Event Text Entries

[186107101] The device is expected to be returned; however, the device has not yet been received. A supplemental report will be submitted if the device is received.
Patient Sequence No: 1, Text Type: N, H10

[186107102] It was reported that a minimum fill notification occurred after filling the cartridge with 300 units of insulin.? Reportedly, a new cartridge was filled and loaded successfully. The customer continued to use the pump for insulin therapy. Customer's blood glucose was 34 mg/dl. Customer consumed juice and glucose tablets to address bg.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3013756811-2020-30266
MDR Report Key9908398
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-10
Device Manufacturer Date2018-10-01
Date Added to Maude2020-03-31
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

Product CodeOYC
Date Received2020-03-31
Model Number1000096
Catalog Number1000911
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer Address11075 ROSELLE STREET SAN DIEGO CA 92121 US 92121


Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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