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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
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2020
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a cartridge alarm 16 occurred with multiple cartridges.Customer¿s blood glucose was 200mg/dl.Reportedly, a new cartridge was loaded to resolve the issue.
 
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Brand Name
T:FLEX INSULIN DELIVERY SYSTEM
Type of Device
INFUSION 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 Key11138931
MDR Text Key225732699
Report Number3013756811-2021-00972
Device Sequence Number1
Product Code LZG
UDI-Device Identifier00852162004569
UDI-Public(01)00852162004569
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number004628-005
Device Catalogue Number007473
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age27 YR
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