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

Model Number 1000096

Device Problem Infusion or Flow Problem (2964)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.

Event Description

It was reported that the customer experienced continuous "erratic" blood glucose (bg 30-over 600 mg/dl).Ketones were moderate.Food was consumed to address low bg and juice/insulin injections/corrective bolus were used to address elevated bg.Customer alleged the pump was the cause of the events and declined tandem technical support¿s offer to perform a system check.Customer reverted to using an alternate pump for insulin therapy and bg returned to target level.

Manufacturer Narrative

The investigation has been completed.Based on the analysis, the alleged device issue could not be verified; however, a different issue was identified.

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: the user entered a blood glucose (bg) of 30 mg/dl on (b)(6) 2018.Immediately following, the user delivered a 4.29 unit bolus for 30 grams of carbs.The user likely entered the bg value of 30 mg/dl in error.The user entered a bg of 24 mg/dl on (b)(6) 2018.Immediately following, the user delivered a 3.7 unit correction bolus for a bg of 240 mg/dl.The user likely entered the bg value of 24 mg/dl in error.Similar likely entry errors occurred several more times during the date range provided.User made bolus requests while still having insulin on board (iob) and without entering current bg level.Delivering a bolus based on incorrectly entered bg or carbohydrate values could lead to a low bg event.Additionally, making bolus requests while still having insulin on board and not entering current bg value could lead to a low bg event.There is no evidence that the insulin pump experienced a malfunction or failure.

• 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: 7864935
• MDR Text Key: 119839000
• Report Number: 3013756811-2018-31018
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007257529930
• UDI-Public: (01)00853052007257529930
• 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,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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: 1000885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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
• Treatment: INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG
• Patient Outcome(s): Other
• Patient Age: 18 YR