MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 1000354

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2022

Event Type  malfunction  

Event Description

It was reported that the customer dropped the pump in a pool and the pump battery was unresponsive.The customer¿s blood glucose level was 150 mg/dl.The customer reverted to an alternate method of insulin therapy.

• Brand Name: T:SLIM G5 SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: michael trier ; 8584011451
• MDR Report Key: 15963639
• MDR Text Key: 307941428
• Report Number: 3013756811-2022-137475
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007318
• UDI-Public: 00853052007318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000354
• Device Catalogue Number: 1000911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2019
• 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 Age: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic