MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM CONTROL IQ INSULIN PUMP; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Model Number 1002633

Device Problems Device Alarm System (1012); Defective Device (2588); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 04/10/2021

Event Type  malfunction  

Event Description

Patient called to report an extremely urgent situation pertaining to his tandem control-iq insulin pump.Patient stated that the device lacks basic alarms that need to be included in the device to keep patients safe.Patient stated the basic control/alarm is lacking mathematically, the units of insulin per 24-72 hours and how much insulin is still on board is incorrect, and when incorrect the pump will just shut off.Patient stated this happened to him 3 times in the last week and a half.Patient stated he loaded 285 units of insulin less than 36 hours ago, only used 75 units and the device says he has 65 units on board.Patient stated the pump does not track daily insulin consumption correctly and does not alarm or alert to the problem and will just shut down.Patient stated another big issue is that the manufacturer's customer service is overwhelmed and incapable of troubleshooting problems that they acknowledge they do have.Patient stated he initially reported his issue to the manufacturer 48 hours ago and reached a recording to leave a message due to a high volume of calls.Patient stated several hours later, he reached out to people he knows on the management team, and finally got a response 7 hours after his initial call all while in an urgent situation due to pump malfunction.Patient said he was told a new pump would be shipped to him and arrive wednesday evening, however he was in an urgent need of a new pump.Patient said the manufacturer is aware the device has problems and acknowledged that the issue is widespread.Patient stated the manufacturer's customer service is severely lacking and are not equipped for what they are doing, and necessary controls are not in place.Patient stated this device urgently needs to be recalled and needs intimidate attention from fda.

• Brand Name: TANDEM CONTROL IQ INSULIN PUMP
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 12590251
• MDR Text Key: 275910440
• Report Number: MW5104464
• Device Sequence Number: 1
• Product Code: QJI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1002633
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR