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 Bruise/Contusion (1754); Hypoglycemia (1912)

Event Date 11/03/2019

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 low blood glucose (bg) of 31 mg/dl; cause was unknown.Reportedly, the customer fell and sustained a bruise due to low bg.Paramedics administered glucagon to treat bg level.Additionally, the customer consumed food to treat bg level.Recommendation was made to consult with healthcare provider regarding diabetes management.

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: an alert 48 (cgm no readings alert) enunciated at 12:17:27 pm on 10/31/2019 indicating a temporary sensor failure ¿---" for more than 20 minutes.This issue resulted in no cgm readings again until 11/5/2019.Therefore, no cgm readings were observed on 11/1/2019.The lowest bg entered into the pump by the user on 11/3/2019 was 150 mg/dl.Therefore, the complaint cannot be confirmed.A tubing fill of size 19.9 units was observed on 11/3/2019 at 8:04:15 am.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.On 11/3/2019, user made bolus requests while still having insulin on board (iob).Making bolus requests while still having iob could lead to a low bg event.Allowing the cgm sensor session to be in a ¿---" state prevents the user from continuously monitoring bg and potentially addressing an impending low bg.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
• MDR Report Key: 9315853
• MDR Text Key: 166175249
• Report Number: 3013756811-2019-82031
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007301
• UDI-Public: (01)00853052007301
• Combination Product (y/n): N
• PMA/PMN Number: P180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 58