FDA Adverse Event Other Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1371664 · Received February 12, 2009

Report

Report Number: 3004464228-2009-00089
Event Type: Other
Date Received: February 12, 2009
Date of Event: January 15, 2009
Report Date: January 15, 2009
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 PRODUCT HAS NOT BEEN 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 KING WAS NOTED IN THE CANNULA. THERE WAS NO REPORT OF AN ALARM, HOWEVER, 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 PRODUCT 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, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS.

Description of Event or Problem · 1

CUSTOMER'S MOTHER CALLED TO REPORT A POD THAT WAS WORN FOR 1 DAY AND REMOVED DUE TO ELEVATED BLOOD GLUCOSE LEVELS THAT RANGED BETWEEN 336 MG/DL - HIGH. CUSTOMER CONTINUED TO INGEST CARBOHYDRATES WHILE BLOOD GLUCOSE LEVELS WERE ELEVATED. UPON POD REMOVAL, THE CUSTOMER FELT THE CANNULA WAS KINKED AND THE SITE WAS NORMAL. CUSTOMER WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY. NO FURTHER ISSUES WERE IDENTIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L30061

Patients

Seq	Age	Sex	Outcome	Treatment
1	16 YR		Other