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

Model Number 4628-003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Virus (2136)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the customer experienced elevated blood glucose (bg) levels (300-400 mg/dl).Reportedly, the pump settings need to be adjusted.Contact stated the customer has a virus/infection.Customer delivers a bolus to bring bg levels back to target range.Recommendation was made to discuss diabetes management with customer's health care professional.

Manufacturer Narrative

(b)(4).

• Brand Name: T:SLIM G4 SYSTEM
• 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: 6395711
• MDR Text Key: 69608048
• Report Number: 3007981285-2017-06857
• Device Sequence Number: 1
• Product Code: OYC
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4628-003
• Device Catalogue Number: 007829
• Other Device ID Number: (01)852162004439(21)501692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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: 10 YR