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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1000096
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Abrasion (1689); Hypoglycemia (1912); Seizures (2063)
Event Date 07/25/2020
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 went to the emergency room (er) due to blood glucose (bg) level ranging from 16-33 mg/dl, and a seizure causing abrasions. Customer alleged that the pump delivered 24 units of insulin, when customer was attempting to correct for 24 grams of carbohydrates consumed. Pump data review confirmed the pump was functioning as intended as data shows customer requested 24 units of insulin, and did not enter a carbohydrate amount. Additionally, customer's max hourly bolus rate was set to 25 grams, so customer would not have received a warning message; however customer maintained that pump was not functioning as intended. Bg was treated with carbohydrates, and an unspecified intravenous treatment. Reportedly, customer left the emergency room 3-4 hours later with customer in stable condition (bg in the 200's mg/dl).
 
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Brand NameT:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of DeviceAUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key10832919
MDR Text Key216090141
Report Number3013756811-2020-126606
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000911
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
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