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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 Obstruction of Flow (2423)
Patient Problems Hyperglycemia (1905); Seizures (2063); Diabetic Ketoacidosis (2364)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative
Per tandem¿s t:slim x2 g6 user guide: ¿do not use any other insulin with your system other than u-100 humalog or u-100 novolog. Only humalog and novolog have been tested and found to be compatible for use in the system. " no product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the customer went to the emergency room (er) and was subsequently hospitalized due to blood glucose level reaching 563 mg/dl and diabetic ketoacidosis. In addition, it was reported that the customer experienced a seizure when the customer attempted to deliver a bolus. Customer was treated with 2 subcutaneous of insulin and fluids, and an intravenous insulin and fluid drip. The customer was released from the hospital on (b)(6) 2020 with no reported permanent damage. Reportedly, an occlusion alarm had occurred. Customer was using fiasp insulin. Tandem technical support educated customer regarding cartridge/insulin labeling. Reportedly, the infusion set was changed to address the issue and insulin delivery was resumed.
 
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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 Key9923950
MDR Text Key188222013
Report Number3013756811-2020-30753
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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: 04/03/2020 Patient Sequence Number: 1
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