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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 1000354
Device Problems Mechanical Problem (1384); Pumping Stopped (1503); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2021
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 a malfunction alarm occurred. Additionally, it was reported that multiple cartridge alarms 20 occurred during the load sequence. The customer reverted to manual injections for insulin therapy. There was no impact to customer¿s blood glucose.
 
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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 Key11230959
MDR Text Key229640190
Report Number3013756811-2021-04960
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 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000354
Device Catalogue Number1000912
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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