MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP

Model Number 1000096

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Hyperglycemia (1905); Vomiting (2144)

Event Date 01/30/2019

Event Type  Injury  

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.Device not returned.

Event Description

It was reported that multiple occlusion alarms occurred.Multiple supply changes were performed and additional occlusion alarms occurred.A system check was performed and the occlusion was found in the tubing.An infusion set change was performed and the occlusion alarms continued.Customer experienced a blood glucose (bg) level ranging between 200-600 mg/dl, ketones, shortness of breath and vomiting resulting in an er visit and subsequent hospitalization.Customer performed supply changes, delivered correction boluses and administered manual injections prior to the er visit/hospitalization.An insulin drip, nausea medication, electrolytes and a chest x-ray were administered/performed in the er/ hospital.At the time of the report, the customer remained hospitalized.Reportedly, the customer reverted to manual injections for insulin therapy.Tandem technical support attempted to contact the customer multiple times to obtain the hospitalization release date; however, no response was received.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: INSULIN PUMP
• 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 Key: 8354590
• MDR Text Key: 136650713
• Report Number: 3013756811-2019-07353
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004781
• UDI-Public: (01)00852162004781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INFUSION SET: TRUSTEEL, INSULIN: HUMALOG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR