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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 03/09/2022
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 the customer went to the emergency room (er) and subsequently admitted to the hospital¿s intense care unit with an low blood glucose (bg) level of 10 mg/dl. Reportedly, the customer delivered too large of a bolus and lost consciousness. Reportedly, customers husband had to call paramedics to be transported to the emergency room (er). During hospital stay, customer was treated intravenously with fluids of saline. Customer was released from hospital on (b)(6) 2022 with issue resolved and no permanent damage. Systems check with tandem technical support confirmed the pump is functioning as intended.
 
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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 Key14241333
MDR Text Key290370225
Report Number3013756811-2022-42035
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
Report Date 04/07/2022
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 Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2019
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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