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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 (2993)
Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Tachycardia (2095)
Event Date 09/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. " (b)(4). 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 experienced a blood glucose (bg) level of 592 mg/dl and large ketones (diabetic ketoacidosis). The cause of elevated bg was unknown. Reportedly, customer experienced weakness, stomach pain, vomiting, and a rapid heart rate. The customer went to the emergency room and was subsequently hospitalized. Bg was treated with manual insulin injection, potassium chloride, intravenous fluids, and medication to treat heart rate, vomiting, and pain. Reportedly, the customer was released on (b)(6) 2019 with the issue resolved and no permanent damage. Tandem technical support (cts) performed system check with customer and verified that pump and supplies were functioning as intended. Reportedly, the customer was using admelog insulin. Cts educated the customer on insulin labeling. Customer acknowledged.
 
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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 Key9207884
MDR Text Key162836812
Report Number3013756811-2019-71028
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 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000103
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 Received09/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2017
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: 10/18/2019 Patient Sequence Number: 1
Treatment
INSULIN: ADMELOG. INFUSION SET: AUTOSOFT 30.
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