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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 Obstruction of Flow (2423)
Patient Problems Fainting (1847); Hyperglycemia (1905)
Event Date 06/05/2020
Event Type  Injury  
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 an occlusion alarm occurred.Customer's blood glucose (bg) level elevated to 600 mg/dl, and subsequently, the customer fainted.Customer required assistance administering a 30 unit manual insulin injection to address elevated bg.Reportedly, pump supplies were changed to address the issue and insulin delivery was resumed.Customer continued to use the pump for insulin therapy.
 
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Brand Name
T:SLIM G5 SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key10214286
MDR Text Key197024343
Report Number3013756811-2020-70070
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00853052007271
UDI-Public00853052007271
Combination Product (y/n)N
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000891
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INSULIN: NOVOLOGINFUSION SET: AUTOSOFT 30, AUTOSO; INSULIN: NOVOLOGINFUSION SET: AUTOSOFT 30, AUTOSO
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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