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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 Problems Failure to Sense (1559); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2019
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 the pump touch screen was scratched and intermittently unresponsive.Reportedly, the reason for the cracked screen was unknown.There was no reported impact to the customer's blood glucose level.Multiple attempts were made by tandem technical support to follow-up with the customer on the reported issue, but no response was received.
 
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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 Key8827987
MDR Text Key152248035
Report Number3013756811-2019-44084
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00853052007271
UDI-Public00853052007271
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 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000891
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age43 YR
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