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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 Partial Blockage (1065)
Patient Problems Tachycardia (2095); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Device not returned.
 
Event Description
It was reported that the customer's blood glucose (bg) was 479 mg/dl and ketones were present. A bolus was delivered to address bg. Customer was vomiting, had trouble breathing and heart rate was elevated. Customer was admitted to the hospital. Healthcare provider identified ketones as dangerous. Intravenous insulin and saline were administered. Elevated bg/ketones were resolved with no permanent injury. Pump system check was performed with tandem technical support and air bubbles were observed in the infusion set tubing. At the time of the report, customer had not yet been discharged. Although multiple attempts were made by tandem technical support to obtain the discharge date, contact did not reply. Reportedly, upon discharge the pump supplies were changed and insulin therapy 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
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key8632486
MDR Text Key145788877
Report Number3013756811-2019-27465
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 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
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 Received04/30/2019
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: 05/22/2019 Patient Sequence Number: 1
Treatment
INFUSION SET: AUTOSOFT XC, INSULIN: HUMALOG
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