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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 Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
Event Type  malfunction  
Event Description
It was reported that an unspecified malfunction occurred.Multiple contact attempts were made by tandem technical support to obtain additional information regarding the issue; however, the customer did not respond.No additional patient or event information was available.
 
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
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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
michael trier
8584011451
MDR Report Key16062842
MDR Text Key306722246
Report Number3013756811-2022-149626
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 Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1000096
Device Catalogue Number1000897
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age22 YR
Patient SexFemale
Patient EthnicityNon Hispanic
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