MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1000354

Device Problem Date/Time-Related Software Problem (2582)

Patient Problem Hyperglycemia (1905)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Per tandem¿s t:slim x2 g6 user guide: ¿do not use any other insulin with your system other than u-100 humalog or u-100 novolog.Only humalog and novolog have been tested and found to be compatible for use in the system." the t:slim x2 g6 pump user guide states: "you tapped stop insulin in the options menu and insulin delivery has been stopped for more than 15 minutes." 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 an elevated blood glucose (bg) level that reached 572 mg/dl.A correction bolus via the pump was delivered to address bg.Reportedly, high bg was due to the customer not resuming insulin delivery after the pump was charged.Subsequently, an alarm resume pump alarm occurred.During a system check with tandem technical support, it was discovered that the pump time and date were incorrect.Tandem technical support assisted customer in correcting the pump time and date, and customer resumed insulin therapy.Additionally, customer was using admelog insulin.Tandem technical support educated customer regarding cartridge/ insulin labeling.Recommendation was made to consult with a healthcare provider to discuss diabetes management.

• 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: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 11088497
• MDR Text Key: 224092854
• Report Number: 3013756811-2020-149674
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613731
• UDI-Public: 00850006613731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000354
• Device Catalogue Number: 1006379
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: INSULIN: ADMELOG
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 35