OMNIPOD INSULIN PUMP

Report

Report Number: 3004464228-2010-01314
Event Type: Injury
Date Received: October 14, 2010
Date of Event: September 15, 2010
Report Date: September 16, 2010
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K042792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE POD WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER STATED THAT A KINK WAS SEEN IN THE CANNULA. THERE WAS, HOWEVER, NO REPORT OF AN OCCLUSION ALARM. THE POD WOULD HAVE INITIATED AN OCCLUSION ALARM IF THE FLOW OF INSULIN WAS RESTRICTED/PREVENTED BY THE KINK AND RESULTED IN BACK PRESSURE. THE OMNIPOD USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY IN ORDER TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PATIENT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT HIS BG LEVELS WERE "HIGHER THAN EXPECTED" WHILE WEARING THIS POD. HIS LEVELS SPIKED WITHIN SIX HOURS OF ACTIVATING THE POD; OVER THE FOLLOWING 12 HOURS, HIS LEVELS REMAINED CONSISTENTLY HIGH (286MG/DL - GREATER THAN 500MG/DL) AND HE HAD LARGE KETONES DESPITE HAVING ADMINISTERED NUMEROUS CORRECTION BOLUSES. AS A RESULT, HE WAS TAKEN ON THE EMERGENCY ROOM WHERE HE WAS PLACED ON AN IV. THE CANNULA WAS REPORTEDLY KINKED, YET THERE WAS NO "INDICATION OF ALARM". THE POD WAS DEACTIVATED AND DISCARDED AT THE HOSPITAL AND, THEREFORE, WILL NOT BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L30360

Patients

Seq	Age	Sex	Outcome	Treatment
1	15 YR		Required Intervention