MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1000096

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

Patient Problems Hyperglycemia (1905); Myocardial Infarction (1969); Visual Impairment (2138)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

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. " no product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Device not returned.

Event Description

It was reported that the customer experienced a blood glucose (bg) level of 1100 mg/dl and diabetic ketoacidosis. Reportedly, the customer had experienced vomiting due to e. Coli food poisoning. The customer and healthcare provider were unsure of the cause of elevated bg; however noted that it may have been related to the food poisoning. The customer went to the emergency room and was subsequently hospitalized. Bg was treated with intravenous insulin and fluids. Reportedly, the customer was released on (b)(6) 2019 with the issue resolved. Reportedly, elevated bg impacted customer's heart requiring customer to use beta-blocker medication (type of heart condition was not specified). Customer also noted that vision impairment as a result of elevated bg. Reportedly, customer was using fiasp insulin. Tandem technical support educated the customer on insulin labeling. Customer acknowledged.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• 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: 8945934
• MDR Text Key: 155999284
• Report Number: 3013756811-2019-54984
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• 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 Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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: 08/29/2019 Patient Sequence Number: 1