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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 Pumping Stopped (1503)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/24/2020
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 multiple intermittent cartridge alarms (alarm 01) occurred with multiple cartridges during basal deliveries.A new cartridge was successfully loaded to address the event.The customer's blood glucose level was 140 mg/dl.
 
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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 Key10289128
Report Number3013756811-2020-73805
Device Sequence Number825853
Product Code LZG
UDI-Device Identifier00852162004606
UDI-Public(01)00852162004606
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K143189
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/17/2020
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 Lay User/Patient
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 06/24/2020
Initial Report FDA Received Date07/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age54 YR
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