MAUDE Adverse Event Report: TANDEM CAMDEN XM CONTROL IQ; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the patient said now they have a camdem (suspected to be tandem) xm device with control iq, but it is not working either.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CAMDEN XM CONTROL IQ
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM
• MDR Report Key: 17530210
• MDR Text Key: 321419161
• Report Number: MW5137130
• Device Sequence Number: 1
• Product Code: QJI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1