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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR

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TANDEM DIABETES CARE T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 1000096
Device Problem Failure to Sense
Event Date 01/08/2020
Event Type  Malfunction  
Manufacturer Narrative

The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be filed upon completion of the evaluation.

 
Event Description

It was reported that the wake button was unresponsive. The customer confirmed the pump display turned on when plugged into a power source. Customer¿s blood glucose was 187 mg/dl. Reportedly, the customer continued to use the pump for insulin therapy.

 
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Brand NameT:SLIM G5 SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
mick trier
san diego , CA 92121
8584011451
MDR Report Key9656099
Report Number3013756811-2020-12357
Device Sequence Number1
Product CodeOYC
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
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 Number1000096
Device Catalogue Number1000911
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2018
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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