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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 Problems Bent (1059); Out-Of-Box Failure (2311)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2018
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 a cartridge appeared to be bent.The cartridge was not used for insulin therapy.Blood glucose level was not impacted.
 
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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
Manufacturer Contact
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key7349675
MDR Text Key102779169
Report Number3013756811-2018-08143
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000885
Other Device ID Number(01)00853052007257
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
INFUSION SET: QUICKSET, INSULIN: NOVOLOG
Patient Age18 YR
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