MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 1000096

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Memory Loss/Impairment (1958)

Event Date 05/29/2021

Event Type  Injury  

Manufacturer Narrative

Pump user guide states: your pump can stop insulin delivery and alert you (or whoever is with you) if there has been no interaction with the pump within a specified period of time.The default for this alarm is pre-set to 12 hours.You can set it anywhere between 5 and 24 hours, or off.The pump user guide states, "tandem diabetes care, inc.Recommends periodically checking the battery level indicator, charging the pump for a short period of time every day (10 to 15 minutes), and also avoiding frequent full discharges".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) level ranging from 400-500 mg/dl resulting in memory loss and loss of balance.The customer went to the emergency room and was subsequently hospitalized.Bg was treated with intravenous fluids.Additionally, customer received physical and speech therapy.Reportedly, the customer was released on 6/17/2021 with the issue resolved; however customer indicated the memory loss was permanent.Pump data review by tandem technical support showed that an auto-off alarm occurred prior to the event.Customer confirmed that there had been no interaction with the pump for an extended period.Additionally, pump data showed that the pump battery fully depleted and the pump shut off due to the customer not charging the pump.Multiple contact attempts were made by tandem technical support to obtain additional information regarding the event and report the pump data findings; however, no response was received from the customer.

• 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 Key: 12145737
• MDR Text Key: 260838987
• Report Number: 3013756811-2021-71922
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007295
• UDI-Public: (01)00853052007295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2021

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 Number: 1000096
• Device Catalogue Number: 1000897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR