MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MMOL/L; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1002717

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Injury (2348)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.

Event Description

It was reported that the customer's blood glucose (bg) was 450 mg/dl and ketones were present (value not provided).Reportedly an "injury" occurred; however, no details were provided.An insulin pen was administered to address elevated bg and assistance was provided by the clinic nurse.Customer's parent alleged pump was faulty.Recommendation was made for contact to discuss event with their healthcare provider.Reportedly, customer reverted to an alternate method of insulin therapy.Although multiple attempts were made to obtain additional information, no response was received.

• Brand Name: T:SLIM X2, BASAL-IQ, MMOL/L
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• 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: 10454371
• MDR Text Key: 204379228
• Report Number: 3013756811-2020-90398
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613021
• UDI-Public: (01)00850006613021
• Combination Product (y/n): N
• PMA/PMN Number: P180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

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: 1002717
• Device Catalogue Number: 1004223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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