FDA Adverse Event Other Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1307797 · Received February 4, 2009

Report

Report Number: 3004464228-2009-00071
Event Type: Other
Date Received: February 4, 2009
Date of Event: January 8, 2009
Report Date: January 8, 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 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 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 PATIENT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS.

Description of Event or Problem · 1

CUSTOMER CALLED TO SAY THAT SHE DID NOT THINK HER POD WAS WORKING PROPERLY BECAUSE HER BLOOD GLUCOSE LEVELS HAD BEEN ELEVATED BETWEEN 307-500 MG/DL. CUSTOMER WAS WEARING THE POD FOR ABOUT 36 HOURS. CUSTOMER STATED THAT WHEN THE POD WAS REMOVED THE CANNULA WAS BENT. CUSTOMER STATED THAT SHE DID NOT SEE BLOOD AROUND THE SITE OR IN THE CANNULA. CUSTOMER WAS ABLE TO ACTIVATE A NEW POD. 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	L11778

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR		Other