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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 Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2020
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 the cartridge was leaking at the patient line. Customer loaded a new cartridge to address the issue. Customer's blood glucose was 174 mg/dl.

 
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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 Key11048210
MDR Text Key223156257
Report Number3013756811-2020-145287
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1002717
Device Catalogue Number1005698
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/23/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/12/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2020
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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