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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 Problem Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Device not returned.
 
Event Description
It was reported that an occlusion alarm (alarm 2) occurred.Reportedly, the customer changed the pump supplies and resumed insulin delivery.The customer's blood glucose level was 400 mg/dl.
 
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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
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key7651663
MDR Text Key112776882
Report Number3013756811-2018-22268
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
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
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 Number007829
Device Lot NumberM019579
Other Device ID Number(01)852162004439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
INSULIN: HUMALOGINFUSION SET: COMFORT SHORT
Patient Age37 YR
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