MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2, BASAL IQ, MG/DL; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1002717

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

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.Per user guide: the pump is indicated for use in individuals six years of age and greater.For patients who do not self-manage their disease, the security pin function should always be on when the pump is not being used by a caregiver.The security pin function is intended to prevent inadvertent screen taps or button presses that may lead to insulin delivery or changes in the pump settings.These changes can potentially lead to hypoglycemia (low bg) or hyperglycemia (high bg) events.

Event Description

It was reported that after removing/reinserting pump cartridge and performing the fill tubing step, the (b)(6) year old customer experienced low blood glucose ( bg 38 mg/dl) and loss of consciousness.Customer's parent treated customer with "re-sugaring by ½ sugar (1 usual sugaring)".Customer regained consciousness.Bg was 53- 55 mg/dl and a bottle of sweet cocoa/sugar was provided.Customer was brought and admitted to the hospital.Bg was 75 mg/dl.Sugar was provided and bg normalized.Customer was discharged the same day with no permanent damage.Cause of low bg was not known.Parents reported not to have handled pump and thought customer may have been handling pump at time of event.Pump did not have a security pin code programed into the pump at the time of event.Customer's healthcare provider reported "inconsistencies in the feasibility of handling the pump by the child" and had the opinion that the cartridge would be too difficult to be removed by a child and as the bg value was manually entered, an adult had to have handled the pump at time of event.Upon receiving the pump, the distributor performed a history review.Distributor thought that a possible handling error may have occurred during the fill tubing step (infusion set not disconnected from customer) and customer may have received 12.7u of insulin (patient is on average on 7 to 8u/day).Customer reverted to using another tandem pump and a security pin was activated.No further issues were reported.

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: there is no evidence that the pump experienced a malfunction or failure.

• Brand Name: T:SLIM X2, BASAL IQ, MG/DL
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 13334725
• MDR Text Key: 284308363
• Report Number: 3013756811-2022-03944
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007998
• UDI-Public: (01)00853052007998
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002717
• Device Catalogue Number: 1004219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Ethnicity: Non Hispanic