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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G4 SYSTEM; INSULIN PUMP
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TANDEM DIABETES CARE T:SLIM G4 SYSTEM; INSULIN PUMP Back to Search Results
Model Number 4628-003
Device Problems Battery Problem (2885); Charging Problem (2892); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2020
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 the pump battery depletes faster than expected.In addition, it was reported that the usb cable has to be held a certain way for the pump to charge.There was no reported impact to the customer's blood glucose level.Customer declined to troubleshoot with tandem technical support.
 
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Brand Name
T:SLIM G4 SYSTEM
Type of Device
INSULIN 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 Key10340490
MDR Text Key200869004
Report Number3013756811-2020-77955
Device Sequence Number1
Product Code OYC
UDI-Device Identifier852162004439
UDI-Public(01)852162004439
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 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number4628-003
Device Catalogue Number008114
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received07/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2017
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 Age54 YR
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