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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 1000354
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Hyperglycemia (1905); Pain (1994)
Event Date 01/17/2020
Event Type  Injury  
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 the customer experienced a blood glucose (bg) ranging from 300 mg/dl to 490 mg/dl, causing a fall resulting in broken t12 vertebrae.The cause of elevated bg was unknown.The customer was transported via the fire department to the emergency room and was subsequently hospitalized in the intensive care unit.Bg was treated with intravenous insulin, and saline.Reportedly, the customer was released on (b)(6) 2020 with the issue resolved, however customer reportedly had ongoing pain from broken vertebrae.System check with tandem technical support confirmed the pump was functioning as intended.
 
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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
mick trier
san diego, CA 92121
8584011451
MDR Report Key11334738
MDR Text Key232088056
Report Number3013756811-2021-17779
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00853052007318
UDI-Public00853052007318
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 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1000354
Device Catalogue Number1000911
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 01/24/2021
Initial Date FDA Received02/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2020
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
INSULIN TYPE: NOVOLOG / NOVORAPID
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age85 YR
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