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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP

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TANDEM DIABETES CARE T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP Back to Search Results
Model Number 004628
Device Problems Obstruction of Flow; Battery Problem
Event Date 01/10/2020
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 depleted quickly. Additionally, it was reported that the customer received intermittent occlusion alarms. There was no reported adverse impact to customer's blood glucose level. Customer declined troubleshooting with tandem technical support, and declined to provide further information.

 
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Brand NameT:SLIM INSULIN DELIVERY SYSTEM
Type of DeviceINSULIN 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 Key9656092
Report Number3013756811-2020-12347
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number004628
Device Catalogue Number007262
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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