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

Model Number 1000096

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problems Hyperglycemia (1905); Renal Failure (2041); Diabetic Ketoacidosis (2364)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.

Event Description

It was reported that multiple, intermittent occlusion alarms occurred.Customer performed troubleshooting with health care provider, and indicated that insulin was not coming through the cartridge.Reportedly, the customer changed cartridge and infusion set, however, the occlusion alarms persisted.Although requested by tandem technical support, the customer declined troubleshooting, and to upload pump data for review.Subsequently, the customer experienced a blood glucose (bg) level of 920mg/dl and diabetic ketoacidosis.Subsequently, customer was hospitalized.Bg was treated with intravenous insulin, and saline.Reportedly, the customer was released on (b)(6) 2020 with the issue resolved, however, customer's health care professional reported customer sustained permanent kidney damage.

Manufacturer Narrative

The failure investigation has been completed.Based on the analysis, the occlusion alarm allegation was verified in the pump logs; however, no failure was identified.Additionally, the cartridge undefined allegation could not be confirmed as the cartridge was not returned.

• 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 Key: 10620405
• MDR Text Key: 209597408
• Report Number: 3013756811-2020-106935
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007257
• UDI-Public: (01)00853052007257
• Combination Product (y/n): N
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 24 YR
• Patient Weight: 74