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

Model Number 1000096

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/14/2018

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 was hospitalized for a hypoglycemic event.Customer¿s blood glucose dropped to 19m/dl.Customer ate a fast food/high carbohydrate meal and delivered a bolus via the pump when blood glucose was 65 mg/dl.Customer reported that healthcare had educated him not to bolus if blood glucose was under 80 mg/dl.Customer also reported that he was educated on fast food taking longer to digest but he delivered the bolus before the carbs were digested.Customer was given cranberry juice while hospitalized to resolve the issue.Customer was discharged from the hospital the following day with no permanent damage.

• 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: julia kensick ; 11075 roselle st.; san diego, CA 92121 ; 8583666900
• MDR Report Key: 7386104
• MDR Text Key: 103975079
• Report Number: 3013756811-2018-10362
• 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
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000885
• Device Lot Number: 5143834
• Other Device ID Number: (01)00853052007257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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: HUMALOG, INFUSION SET: INSET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR