FDA Adverse Event Injury Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1910260 · Received November 23, 2010

Report

Report Number: 3004464228-2010-01384
Event Type: Injury
Date Received: November 23, 2010
Date of Event: October 21, 2010
Report Date: October 21, 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 INVOLVED 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 OMNIPOD USER GUIDE INSTRUCTS USERS TO CHECK BLOOD GLUCOSE LEVELS OF FREQUENTLY, SO THAT THEY'RE ABLE TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE USER GUIDE ALSO ADVISES THAT, IF BG LEVELS REMAIN HIGH FOUR HOURS AFTER A BOLUS WAS FIRST ADMINISTERED, THEN THE POD SHOULD BE REPLACED AND A HEALTHCARE PROVIDER SHOULD BE CONTACTED FOR GUIDANCE. A FOLLOW-UP REQUEST FOR ADDITIONAL INFORMATION ABOUT THE DEVICE AND THE EVENT WAS MADE, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

Description of Event or Problem · 1

THE CUSTOMER'S MOTHER REPORTED THAT HER SON HAD EXPERIENCED HIGH BG LEVELS (331MG/DL) WITH MODERATE KETONES. AS A RESULT OF, HE "SPENT PART OF THE WEEKEND IN THE HOSPITAL." THE REPORT IMPLIES THAT THE MOTHER HAD ATTEMPTED TO DELIVER CORRECTION BOLUSES TO TREAT THE HIGH BG'S, BUT, DESPITE THIS, HIS LEVELS WOULD NOT LOWER. THE MOTHER ENDED THE CALL IN ORDER TO TEND TO HER SON. A FOLLOW-UP REQUEST TO OBTAIN ADDITIONAL INFORMATION ABOUT THE DEVICE AND THE EVENT WAS UNSUCCESSFUL. THE POD 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	UNAVAILABLE

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 YR		Hospitalization