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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 1002717
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypoglycemia (1912)
Event Date 04/10/2022
Event Type  Injury  
Event Description
It was reported that the customer experienced a low blood glucose (bg) level of 90 mg/dl resulting in a visit to the emergency room (er). Cause of low bg was due to the customer accidentally bolusing a 20-unit bolus instead of a 2-unit bolus. The customer drank 1 liter of soda on the way to the er, and a second liter of soda while at the er. The customer was monitored and did not receive any additional treatment as the consumption of soda resolved the adverse event. The customer left the er with the issue resolved and no permanent damage sustained. No issues were identified with the pump or any of the supplies in use at the time of the event.
 
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Per tandem's user guide: always confirm that the decimal point placement is correct when entering bolus information. Incorrect decimal point placement can prevent you from getting the proper amount of insulin that your healthcare provider has prescribed for you.
 
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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 Key14245020
MDR Text Key290372073
Report Number3013756811-2022-42573
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002717
Device Catalogue Number1002684
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2020
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: 04/28/2022 Patient Sequence Number: 1
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