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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 Pumping Stopped (1503)
Patient Problem No Patient Involvement (2645)
Event Date 04/14/2020
Event Type  malfunction  
Event Description
It was reported that a malfunction alarm occurred after customer removed the pump from the box and began charging it.There was no impact to blood glucose as the malfunction occurred before the customer was able to begin using the pump for insulin therapy.Reportedly, the customer reverted to manual injections 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
11075 roselle street
san diego CA 92121
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key10029788
MDR Text Key190132837
Report Number3013756811-2020-44794
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00853052007318
UDI-Public00853052007318
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 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
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 Age14 YR
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