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

Model Number 1000096

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

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Hypoglycemia (1912)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

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 20 mg/dl.Subsequently, customer's bruised their head and broke their foot.Customer's broken foot was treated and soda was consumed to treat bg.Customer did not provide further information on broken foot or treatment administered.While sleeping customer alleged pump increased the basal setting.Tandem technical support (cts) reviewed pump data and no pump issues were identified.No unplanned changes in the basal rates were identified; basal rates only changed according to their programmed times.Customer acknowledged information.Cts recommended customer discuss event with a healthcare provider.

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: lowest blood glucose (bg) entered into the pump by the user during the week prior to (b)(6)2019 was 53 mg/dl on (b)(6)2019 at 1:51 pm.Prior to the low bg, there were no obvious requests or deliveries that would cause bg levels to drop.User requested a 6.16 unit bolus at 9:07 am for 40 grams of carbohydrates and a bg of 202 mg/dl.There were no erratic basal rate adjustments.During the week prior to (b)(6)2019, user made bolus requests while still having insulin on board (iob) and the cartridge change sequence was completed several times.Making bolus requests while still having iob could lead to a low bg event.If user did not disconnect during the ¿fill tubing¿ step of the cartridge change sequence, insulin would be delivered, and this could cause bg levels to drop.There is no evidence that the pump experienced a malfunction or failure.

• 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: 8759324
• MDR Text Key: 149986412
• Report Number: 3013756811-2019-37806
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AUTOSOFT 90, INSULIN: NOVOLOG
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 56 YR