MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 1000096

Device Problem Material Deformation (2976)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

Per the t:slim x2 g5 pump user guide: "hold the cartridge upright and gently insert the needle into the white insulin fill port on the cartridge.The needle is not intended to go all the way in, so do not force it." 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 was hospitalized due to diabetic ketoacidosis and a blood glucose (bg) level of 604 mg/dl.Customer was treated with insulin via manual injection to treat bg and dka.Reportedly, the customer was released two days later with the issue resolved and no permanent damage.Reportedly, elevated bg occurred due to cartridge damage caused by the customer forcing the syringe needle too far inside the cartridge fill port when attempting to fill the cartridge with insulin.

• Brand Name: T:SLIM G5 SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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: 8712155
• MDR Text Key: 148424546
• Report Number: 3013756811-2019-34516
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007295
• UDI-Public: (01)00853052007295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2019

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: 1000897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 95