T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY 1000096 1000886

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY 1000096 1000886 manufactured by Tandem Diabetes Care.

Event Text Entries

[186855716] No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[186855717] It was reported that the pump did not "dose correctly. " customer declined troubleshooting with tandem technical support and declined to provide further information. There was no reported impact to customer? S blood glucose.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013756811-2020-30405
MDR Report Key9908415
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-09-01
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

Brand NameT:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Generic NameAUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Product CodeOZO
Date Received2020-03-31
Model Number1000096
Catalog Number1000886
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTANDEM DIABETES CARE
Manufacturer Address11075 ROSELLE STREET SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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