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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 Power Up (1476); Out-Of-Box Failure (2311)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2017
Event Type  malfunction  
Manufacturer Narrative
The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.
 
Event Description
It was reported that upon initially receiving the pump, the pump was unable to be turned on despite the attempt of multiple usb cables and power sources.There was no impact to the customer's blood glucose level, as the pump was not being used on the customer at the time of the event.Reportedly the customer had an alternate pump and manual injection supplies available for insulin therapy.
 
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Brand Name
T:SLIM G5 SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
TANDEM DIABETES CARE
11045 roselle street
san diego CA 92121
Manufacturer Contact
julia kensick
11045 roselle st.
san diego, CA 92121
8583666900
MDR Report Key7007332
MDR Text Key91909879
Report Number3007981285-2017-32672
Device Sequence Number1
Product Code OYC
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 Patient
Type of Report Initial,Followup
Report Date 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000885
Other Device ID Number(01)00853052007257
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age38 YR
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