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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 09/22/2022
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Device not returned.
 
Event Description
It was reported that the wake button was unresponsive.There was no reported adverse impact to customer's blood glucose level.No additional patient or event information was available.
 
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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
michael trier
8584011451
MDR Report Key15596131
MDR Text Key305928654
Report Number3013756811-2022-113116
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002717
Device Catalogue Number1004219
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 Received03/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient EthnicityNon Hispanic
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