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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE TANDEM T:SLIM INSULIN DELIVERY SYSTEM; INSULIN PUMP
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TANDEM DIABETES CARE TANDEM T:SLIM INSULIN DELIVERY SYSTEM; INSULIN PUMP Back to Search Results
Model Number 004628
Device Problem Device Sensing Problem (2917)
Patient Problem No Patient Involvement (2645)
Event Date 10/20/2020
Event Type  malfunction  
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 Description
It was reported that the wake button was unresponsive.Customer confirmed pump display turned on when plugged into a power source.The pump was being used by a tandem territory manager and was not being used for insulin therapy.
 
Manufacturer Narrative
The failure investigation has been completed.Based on the analysis, the alleged issue could not be verified; however, a different issue was identified (malfunction 12-0x2071).
 
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Brand Name
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
Type of Device
INSULIN PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key10824426
MDR Text Key215981218
Report Number3013756811-2020-124305
Device Sequence Number1
Product Code LZG
Combination Product (y/n)N
PMA/PMN Number
K111210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/11/2020
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
Device Operator Lay User/Patient
Device Model Number004628
Device Catalogue Number004629
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received11/11/2020
Supplement Dates Manufacturer Received12/30/2020
Supplement Dates FDA Received12/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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