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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR
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TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 1000096
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2018
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Device not returned.
 
Event Description
It was reported that the cartridge/infusion set tubing luer lock became disconnected; cause was not known.Infusion set was changed.Insulin delivery was resumed.There was no reported impact to blood glucose.
 
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Brand Name
T:SLIM G5 SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key7772682
MDR Text Key116760567
Report Number3013756811-2018-27460
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00853052007295540390
UDI-Public(01)00853052007295540390
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000897
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received07/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
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
INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG
Patient Age61 YR
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