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

Model Number 1002717

Device Problems Crack (1135); Failure to Sense (1559)

Patient Problems Hyperemia (1904); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

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.Device not returned.

Event Description

It was reported that the pump touch screen was cracked and unresponsive.Reportedly, the customers blood glucose was 54 mg/dl.Customer continued to use pump for insulin therapy.

Manufacturer Narrative

B5 h6: remove: 1904, 4613 h6: add: 2199,4582, 1135.B5 h6: remove: 1904, 4613 h6: add: 2199,4582, 1135.

Event Description

It was reported that the pump touch screen was cracked and unresponsive.Reportedly, the customers blood glucose was 58 mg/dl.Customer continued to use pump for insulin therapy.

• 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: 12554370
• MDR Text Key: 274043028
• Report Number: 3013756811-2021-106237
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00085006613373
• UDI-Public: 0085006613373
• 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,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1002717
• Device Catalogue Number: 1005698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR