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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
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/12/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.
 
Event or Problem Description
It was reported that the wake button was unresponsive.Customer confirmed pump display turned on when plugged into a power source.Customer¿s blood glucose was 122 mg/dl.Reportedly, customer continued to use the pump for insulin therapy.
 
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Brand Name
T:SLIM G4 SYSTEM
Common Device Name
INSULIN PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key10785202
Report Number3013756811-2020-119863
Device Sequence Number3500969
Product Code OYC
UDI-Device Identifier00852162004750
UDI-Public00852162004750
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P140015
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number4628-003
Device Catalogue Number008542
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2020
Initial Report FDA Received Date11/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age37 YR
Patient Weight94
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