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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP
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TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP Back to Search Results
Model Number 004628-005
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/18/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that occlusion alarms occurred.Customer changed pump supplies to address the issue and resumed insulin delivery.There was no adverse impact to customer's blood glucose.
 
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Brand Name
T:FLEX INSULIN DELIVERY SYSTEM
Common Device Name
INFUSION PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key12275909
Report Number3013756811-2021-86220
Device Sequence Number4494880
Product Code LZG
UDI-Device Identifier00852162004606
UDI-Public(01)00852162004606
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K143189
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/04/2021
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
Operator of Device No Information
Device Model Number004628-005
Device Catalogue Number007666
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/18/2021
Initial Report FDA Received Date08/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
INFUSION SET: AUTOSOFT 90INSULIN: NOVOLOG
Patient Age45 YR
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