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

Model Number 1002717

Device Problem Partial Blockage (1065)

Patient Problem Hypoglycemia (1912)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

Per the cartridge instructions for use: replace the cartridge every 48 hours if using humalog; every 72 hours if using novolog.Per the user guide: do not disconnect the luer-lock connection between the cartridge tubing and the infusion set tubing.If the connection comes loose, disconnect the infusion set from your body before tightening.Failure to disconnect before tightening can result in over delivery of insulin.This can cause low blood glucose.Per the user guide: always remove all air bubbles from the system before beginning insulin delivery.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's blood glucose (bg) was 45 mg/dl; cause was not known.Customer consumed carbohydrates to address low bg.Reportedly, customer's bg elevated (378 mg/dl).Pump system check found air bubbles in the tubing.Customer reported to have disconnected the from the infusion set tubing at the t:lock versus the infusion set site.Customer primed air out of tubing.Reportedly, customer used cartridge with humalog longer than the labeled 48 hours.Recommendation was made for customer to discuss low bg with their healthcare provider.

• 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: 10079954
• MDR Text Key: 191728802
• Report Number: 3013756811-2020-48932
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/21/2020

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: 1002717
• Device Catalogue Number: 1002684
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• 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: VARISOFT, INSULIN: HUMALOG
• Patient Outcome(s): Other
• Patient Age: 44 YR