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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1002717
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 05/29/2022
Event Type  Injury  
Event Description
It was reported that the customer was hospitalized.Cause of hospitalization was not provided.Multiple attempts were made to obtain additional information; however, no additional information regarding this event was provided.
 
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Device not returned.
 
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Brand Name
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of Device
AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key14659461
MDR Text Key294026757
Report Number3013756811-2022-60931
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002717
Device Catalogue Number1006419
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient EthnicityNon Hispanic
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