FDA Adverse Event Other Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1659036 · Received April 8, 2010

Report

Report Number: 3004464228-2010-01105
Event Type: Other
Date Received: April 8, 2010
Date of Event: March 12, 2010
Report Date: March 12, 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 PRODUCT WAS NOT RETURNED TO THE MFR FOR EVAL. 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 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 IN ORDER TO 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

THE CUSTOMER REPORTED THAT HER BG LEVELS CONTINUED TO RISE AFTER WAKING DESPITE HAVING ADMINISTERED A CORRECTION BOLUS; CONSISTENTLY HIGH BGS WERE EXPERIENCED OVER A TWO HOUR PERIOD (252-295 MG/DL). THE POD WAS REMOVED AND REPLACED; THE NEW POD WAS SUCCESSFUL IN LOWERING HER BGS. A KINK AS WELL AS THE PRESENCE OF BLOOD WAS SEEN IN THE CANNULA OF THE SUSPECT DEVICE, THOUGH NO ALARM WAS INITIATED. THE POD WILL BE RETURNED FOR EVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L30255

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other