FDA Adverse Event Injury Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1933794 · Received December 11, 2010

Report

Report Number: 3004464228-2010-01436
Event Type: Injury
Date Received: December 11, 2010
Date of Event: September 29, 2010
Report Date: November 19, 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 MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE CUSTOMER'S HIGH BG READINGS. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER'S DOCTOR HAD NOTED THAT "THE CANNULA WASN'T IN HER SKIN." A DISPLACED CANNULA IS INDICATIVE OF A SITE SELECTION OR POD PLACEMENT TECHNIQUE ISSUE AND DOES NOT CONSTITUTE A FAILURE OF THE DEVICE. THE OMNIPOD USER GUIDE INSTRUCTS THE USER TO CHECK THE INFUSION SITE FREQUENTLY TO ENSURE PROPER CANNULA PLACEMENT. IF USER GUIDE INSTRUCTIONS WERE PROPERLY FOLLOWED, THE CUSTOMER WOULD HAVE IMMEDIATELY REMOVED AND REPLACED THE POD UPON RECOGNIZED THAT THE CANNULA HAD BECOME DISLODGED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR TWO DAYS "AS A RESULT OF A HEART ATTACK AND KETOACIDOSIS". SHE EXPERIENCED LARGE KETONES AND CONTINUOUSLY HIGH BG LEVELS (363-497 MG/DL) WITHIN THE SECOND DAY OF POD WEAR THAT WOULD NOT LOWER DESPITE HAVING ADMINISTERED MULTIPLE CORRECTION BOLUSES. HER DOCTOR INFORMED HER THAT "THE CANNULA WASN'T IN HER SKIN". THE POD WAS DISCARDED AT THE HOSPITAL AND WILL THEREFORE NOT 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	UNAVAILABLE

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Hospitalization