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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 Filling Problem (1233)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2022
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 insulin drips were not observed to be exiting the infusion set tubing during the load fill tubing process. Customer's blood glucose level ranged from 360-361 mg/dl. Customer continued using the pump for insulin therapy.
 
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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 Key14469470
MDR Text Key292368281
Report Number3013756811-2022-52530
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
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 05/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2022
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 Received06/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
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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