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

Model Number 1000096

Device Problems Disconnection (1171); Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Per tandem¿s pump user guide: ¿check that your connection between the cartridge tubing and the infusion set tubing is tight and secure.¿ no product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a non-tandem infusion set was pulled, and subsequently the cartridge connection became disconnected and damaged.Subsequently, during the fill tubing process, the cartridge leaked from the cartridge connection.Customer's blood glucose level was 161 mg/dl.Reportedly, customer performed a supply change to address the issue.

• 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: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 9681896
• MDR Text Key: 178226240
• Report Number: 3013756811-2020-12455
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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
• Treatment: INSULIN: NOVOLOG/NOVORAPID
• Patient Age: 66 YR