MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM INSULIN PUMP; PUMP, INFUSION, INSULIN

Device Problems Failure to Deliver (2338); Connection Problem (2900)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 09/15/2021

Event Type  Injury  

Event Description

My father, (b)(6), uses a tandem insulin pump.He has used a variety of insulin pumps over the past few decades.On (b)(6) 2021, he changed the insulin cartridge in his tandem pump in the evening.On (b)(6), he woke up vomiting with elevated blood sugars.He was taken to (b)(6) medical center er where his blood glucose was found to be 659.He was admitted to the icu for an insulin drip and electrolyte correction.He was discharged on (b)(6) 2021.While he was in the er and icu, the nursing staff examined the pump and felt that the connection between the cartridge and the pump was not working.The pump said it was administering insulin, but it wasn't.My dad's outpatient endocrinologist, dr.(b)(6) of (b)(6), came to the same conclusion.As requested by the hospital staff, i contacted tandem on (b)(6), regarding the problem and requested a new pump for the defective old pump.At that time, i was told that despite having a life threatening problem requiring an icu stay, that three levels of management would need to approve his new pump.She advised me we would hear back in 3-5 business days.I requested a supervisor call back, which occurred on the afternoon of (b)(6).She shipped a new pump which was received on (b)(6).I did ask for the serial number and model number and they declined to give it to me.They stated it was in his records at the company so i did not need it.Fda safety report id # (b)(4).

• Brand Name: TANDEM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 12532458
• MDR Text Key: 273588155
• Report Number: MW5104197
• Device Sequence Number: 1
• Product Code: LZG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/22/2021

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 99