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 Battery Problem (2885)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 04/14/2019

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 pump battery was observed to be depleting rapidly. The customer provided a blood glucose (bg) range of 10-300 mg/dl and indicated that the customer was known to experience low bg events. Reportedly, the customer experienced a seizure due to low bg and required assistance to consume glucose as treatment. Multiple contact attempts were made by tandem technical support to determine the rate of battery depletion and to obtain additional information regarding the cause of the low bg; however, the customer did not respond.

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: "blood glucose (bg) values below 54 mg/dl were recorded by continuous glucose monitor (cgm) from 10:57-11:12 pm on (b)(6) 2019. Cgm alert 3 (cgm glucose reading below user threshold) and cgm alert 1 (cgm low alert) were annunciated. Cartridge change sequence was completed at 10:54 am with 11. 3 units being primed through the infusion set tubing. User made bolus requests without entering current bg and while still having insulin on board (iob). At 9:36 pm, user requested a 3. 29 unit bolus for 46 grams of carbohydrates without entering current bg and while having 1. 77 units of insulin on board. There were no erratic basal rate adjustments. There is no evidence that the pump experienced a malfunction or failure. 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. Making bolus requests without entering current bg and while still having iob could lead to a low bg event. ".

• 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: 8672736
• MDR Text Key: 147150907
• Report Number: 3013756811-2019-31379
• 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,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1000096
• Device Catalogue Number: 1000912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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: 06/05/2019 Patient Sequence Number: 1