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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM T-SLIM SENSOR, GLUCOSE, INVASIVE

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TANDEM DIABETES CARE, INC. TANDEM T-SLIM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057); Filling Problem (1233); Connection Problem (2900); Improper Flow or Infusion (2954); Activation Failure (3270)
Patient Problem Hyperglycemia (1905)
Event Date 10/01/2020
Event Type  Injury  
Event Description
I received a tandem insulin pump and a dexcom g6 cgm the "artificial pancreas. My cde and i set it up and the first month my blood sugars rarely went below 300 despite bolusing huge amounts of insulin. Proper control was only achieved with a syringe. I believe the issue is a flawed infusion set design discarded by minimed a long time ago. The injector implants the cannula but pulls the cannula out to a degree when needle is extracted. I was able to mitigate this using additional adhesive and trying to hold the set in place with my pinky. This did help but it currently is a rare thing to bolus 15 minutes out and stay under 200. An issue with delivery and absorption. There are additional flaws and irritants to this device including no visual check of reservoir levels. Several times i have bolused 15 units when pump indicates 90 units. When bolus is complete i am now in the red. Rarely have i had a sensor get to 10 days. Normally the sensor gives you multiple sensor error message prior to failure or patient exhaustion of hearing the "profanity" thing beep it's announcement of another error. Injectors fail to deploy and i had a transmitter die prematurely and it took dexcom nearly 2 weeks to provide a new one. There is now an fb page for g6 users. Lots of stories just like mine. Kind of hard to believe this garbage won the designation of artificial pancreas. Fda safety report id# (b)(4).
 
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Brand NameTANDEM T-SLIM SENSOR, GLUCOSE, INVASIVE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
TANDEM DIABETES CARE, INC.
MDR Report Key11398397
MDR Text Key234458231
Report NumberMW5099704
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/25/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/01/2021 Patient Sequence Number: 1
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