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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 Problems Filling Problem (1233); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Tachycardia (2095)
Event Date 07/04/2019
Event Type  Injury  
Manufacturer Narrative
Per the user guide: never fill your tubing while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can result in over delivery of insulin. 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 received a continuous glucose monitor (cgm) error 42. Pump was reset to resolve the issue. Additionally, the customer performed the fill tubing sequence while connected at the site and delivered insulin into the body. Customer blood glucose dropped to 40mg/dl and was treated by consuming 250 grams of carbohydrates. Reportedly, the customer also experienced tachycardia symptoms and chose to reach out to a healthcare provider regarding diabetes management.
 
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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
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key8832284
MDR Text Key152371303
Report Number3013756811-2019-43348
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2017
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: 07/26/2019 Patient Sequence Number: 1
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