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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 05/22/2020
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 wake button was unresponsive.Customer confirmed pump display turned on when plugged into a power source.This pump is being used for demo and not being used by customer at time of event.Tandem technical support made multiple attempts to follow up with the customer and complete troubleshooting; however, a response was not received.
 
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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
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key10150493
MDR Text Key195019604
Report Number3013756811-2020-59700
Device Sequence Number1
Product Code LZG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
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? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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