MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD TRANSMITTER; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Catalog Number SKT-H001-G-X9

Device Problems No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

Complainant called to report omnipod.She stated that she received her transmitter in (b)(6) 2022, and it has been replaced 3 times for failure since (b)(6).As of (b)(6) the most recent replacement is not giving accurate readings and has an error message.Picture of error message will follow complaint.No adverse effects have been reported due to machine failure.Reference reports: mw5117751, mw5117753.

• Brand Name: OMNIPOD TRANSMITTER
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 16983494
• MDR Text Key: 315780245
• Report Number: MW5117752
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: SKT-H001-G-X9
• Patient Sequence Number: 1