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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 Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.
 
Event Description
It was reported that multiple cartridge alarms occurred.Customer's blood glucose was within range (value not provided).Customer reverted to using an alternate method of insulin therapy.
 
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Brand Name
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of Device
AUTOMATED 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 Key11088608
MDR Text Key224265888
Report Number3013756811-2020-148796
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1002717
Device Catalogue Number1002684-A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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