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 Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 04/15/2019

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 experienced a blood glucose (bg) level of 38 mg/dl; cause was unknown.Reportedly, the customer lost consciousness and experienced a seizure.The customer's mother administered a glucagon injection and customer was taken to the emergency room for treatment.The customer received intravenous dextrose and was released 4 hours later with no injuries and bg level of 120 mg/dl.

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: "blood glucose (bg) of ¿low¿ (below 40 mg/dl) was recorded by continuous glucose monitor (cgm) at 11:06 am on (b)(6)2019.Cgm alert 3 (cgm glucose reading below user threshold) and cgm alert 1 (cgm low alert) were annunciated.Bg of 36 mg/dl was entered into the pump by the user at 7:40 pm.User made bolus requests while still having insulin on board (iob), and manually increased the bolus amount from the correction amount recommended by the pump.There were no erratic basal rate adjustments.Making bolus requests while still having iob could lead to a low bg event.It is possible the user¿s personal profile settings need adjustment.There is no evidence that the pump experienced a malfunction or failure.".

• 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: 8612427
• MDR Text Key: 145127817
• Report Number: 3013756811-2019-27741
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007264
• UDI-Public: 00853052007264
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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: TRUSTEEL, INSULIN: NOVOLOG
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 21 YR