FDA Adverse Event Other Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1772209 · Received July 23, 2010

Report

Report Number: 3004464228-2010-01202
Event Type: Other
Date Received: July 23, 2010
Date of Event: June 25, 2010
Report Date: June 25, 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 WAS NOT 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, 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 REPORT INDICATED THAT THE CUSTOMER'S BG LEVELS ROSE AFTER PLACING A NEW POD. HIGH BG'S (303-329 MG/DL) WERE EXPERIENCED WITHIN THREE HOURS OF ACTIVATION DESPITE HAVING ADMINISTERED MULTIPLE BOLUSES. THE CUSTOMER NOTED THAT THE CANNULA WAS KINKED, THOUGH NO ALARM WAS INITIATED. THE POD WAS REMOVED AND REPLACED; HER BG LEVELS SUCCESSFULLY LOWERED WITH THE PLACEMENT OF THE NEW POD. THE SUSPECT DEVICE WILL 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	L30254

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Other