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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 Excess Flow or Over-Infusion (1311)
Patient Problems Fall (1848); Head Injury (1879); Hypoglycemia (1912)
Event Date 05/26/2020
Event Type  Injury  
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.Device not returned.
 
Event Description
It was reported that the customer experienced a blood glucose level of 26 mg/dl and a seizure.Subsequently, the customer fell, the customer¿s head was hit, and the customer¿s hand was cut.Customer was admitted to the hospital and was treated with carbohydrates, and the customer¿s cut hand was stitched.The customer was discharged on (b)(6) 2020 with no permanent damage.Customer alleged that the pump did not deliver insulin as intended.Reportedly the customer reverted to manual injections 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.
 
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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 Key10162183
MDR Text Key195383817
Report Number3013756811-2020-64293
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00853052007318
UDI-Public00853052007318
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 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age21 YR
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