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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 Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Event Description
It was reported that the wake button was unresponsive. Pump display turned on when plugged into a power source. There was no reported impact to the customer's blood glucose (bg) level. Customer continued to use the pump for insulin therapy.
 
Manufacturer Narrative
Device not returned.
 
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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 Key14043995
MDR Text Key288810265
Report Number3013756811-2022-32587
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002717
Device Catalogue Number1004223
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2020
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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