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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 1000096
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2019
Event Type  Death  
Manufacturer Narrative

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.

 
Event Description

It was reported that the customer passed away. Cause of death is pending determination by coroner. Per coroner, customer's blood glucose was reportedly very low at around the time of death. No additional information was provided.

 
Manufacturer Narrative

On november 8, 2019, additional information was received from the medical examiner concluding that the patient¿s death was due to an accidental combination of xanax, oxycodone, methadone and gabapentin. Therefore, the cause of death has been determined to be prescription drug-related and unrelated to tandem¿s insulin pump or supplies.

 
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Brand NameT:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of DeviceAUTOMATED 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 Key9256157
Report Number3013756811-2019-75603
Device Sequence Number1
Product CodeOZO
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000096
Device Catalogue Number1000886
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/30/2019 Patient Sequence Number: 1
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