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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 Failure to Sense (1559); Battery Problem (2885); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Event Description
It was reported that the pump touch screen was unresponsive, the battery was depleting quickly and the wake button was not working. Customer¿s blood glucose level was 200 mg/dl. The customer continued to use the pump for insulin therapy and a replacement pump was sent.
 
Manufacturer Narrative
The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be submitted upon completion of the evaluation.
 
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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 Key14117178
MDR Text Key289319265
Report Number3013756811-2022-36350
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,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1000354
Device Catalogue Number1006379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2020
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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