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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number 1002717
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Pneumonia (2011); Swelling (2091)
Event Date 07/12/2019
Event Type  Injury  
Manufacturer Narrative
The t:slim x2 ous pump user guide states "only your healthcare provider can determine and help you adjust your basal rate(s), carb ratio(s), correction factor(s), target bg, and duration of insulin action.In addition, only your healthcare provider can determine your cgm settings and how you should use your sensor trend information to help you manage your diabetes.Incorrect settings can result in over delivery or under delivery of insulin.This can cause very low or very high blood glucose." 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 a blood glucose (bg) level of 32 mg/dl and became unconscious.Reportedly, the customer was transferred to the hospital via ambulance.Reportedly, the customer experienced "body swelling" and aspiration pneumonia that required the customer to be transferred to a regional hospital for further monitoring on (b)(6) 2019.The customer had reportedly changed basal rates repeatedly without consulting the healthcare provider.Reportedly, the customer consulted the healthcare provider for additional training.No additional information was provided.
 
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Brand Name
T:SLIM X2 INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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 Key8870887
MDR Text Key153578971
Report Number3013756811-2019-46728
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number1002717
Device Catalogue Number1002684
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received08/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
INFUSION SET: AUTOSOFT 90.
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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