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 False Alarm (1013)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2021

Event Type  malfunction  

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.

Event Description

It was reported that an altitude alarm occurred while the customer was not outside of the labeled operating altitude range with multiple cartridges.The customer's blood glucose level was 205 mg/dl.Reportedly, the customer reverted to an alternate method of insulin therapy.

Manufacturer Narrative

The failure investigation has been completed and the alleged issue was verified in the pump logs; however, no failure was identified.Additionally, a different issue was identified.

• 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: 11267092
• MDR Text Key: 229886738
• Report Number: 3013756811-2021-10928
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007325
• UDI-Public: (01)00853052007325
• Combination Product (y/n): N
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000354
• Device Catalogue Number: 1000912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR