MAUDE Adverse Event Report: TANDEM DIABETES CARE TANDEM T:SLIM G4 INSULIN PUMP

Model Number 4628-003

Device Problem Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 12/25/2015

Event Type  Injury  

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.Device not returned.

Event Description

It was reported that an occlusion alarm occurred.The customer's blood glucose (bg) level was impacted (over 400 mg/dl).It was indicated that the customer would take a manual injection.A system check performed by the contact, prior to contacting tandem technical support, identified the cartridge as a possible cause of the occlusion.It was indicated that the cartridge would be changed.

• Brand Name: TANDEM T:SLIM G4 INSULIN PUMP
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11045 roselle street; san diego CA 92121
• Manufacturer Contact: julia kensick ; 11045 roselle st.; san diego, CA 92121 ; 8583666900
• MDR Report Key: 5371811
• MDR Text Key: 36195680
• Report Number: 3007981285-2016-66109
• Device Sequence Number: 0
• Product Code: MDS
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/25/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4628-003
• Device Catalogue Number: 006194
• Device Lot Number: M016323
• Other Device ID Number: (01) 00852162004408 (21)475155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/25/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/25/2016; 05/09/2016; 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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 Outcome(s): Other
• Patient Age: 11 YR
• Patient Weight: 43