MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number 1000354

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/08/2021

Event Type  Injury  

Event Description

It was reported that the customer had surgery to remove infection caused by a non tandem infusion set.There was no reported adverse effect to the customer's blood glucose level.The customer declined assistance from tandem technical support regarding the issue.The infusion set brand and manufacture was not provided.

Manufacturer Narrative

The cause of the reported issue was due to the infusion set.Tandem does not manufacture infusion sets.No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 12869941
• MDR Text Key: 281212885
• Report Number: 3013756811-2021-128029
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007981
• UDI-Public: (01)00853052007981
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1000354
• Device Catalogue Number: 1003808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: INSULIN TYPE: UNKNOWNINFUSION SET: UNKNOWN
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic