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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP

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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP Back to Search Results
Model Number 1000096
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
Per the tandem user guide, "always remove all air bubbles from the pump before beginning insulin delivery.Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling.Air in the system takes space where insulin should be and can affect insulin delivery." no product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that air bubbles were observed in the infusion set tubing.Reportedly, the customer had not performed the air removal process correctly prior to filling the cartridge with insulin.The customer's blood glucose level was 116 mg/dl.Customer changed the pump supplies to resolve the issue.
 
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Brand Name
T:SLIM X2 INSULIN PUMP
Type of Device
INSULIN PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key11848600
MDR Text Key251422435
Report Number3013756811-2021-52646
Device Sequence Number1
Product Code LZG
UDI-Device Identifier00852162004798
UDI-Public(01)00852162004798
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1000096
Device Catalogue Number1000369
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/30/2021
Initial Date FDA Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
INSULIN TYPE: HUMALOGINFUSION SET: VARISOFT
Patient Age75 YR
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