FDA Adverse Event Injury Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1873047 · Received October 14, 2010

Report

Report Number: 3004464228-2010-01316
Event Type: Injury
Date Received: October 14, 2010
Date of Event: September 16, 2010
Report Date: September 16, 2010
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K042792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE POD WILL NOT BE RETURNED FOR EVALUATION. UNABLE TO CONFIRM ANY ISSUE RELATED TO THE POD'S ADHESIVE. THE OMNIPOD USER GUIDE INSTRUCTS PATIENTS TO CHECK THE INFUSION SITE DAILY FOR SIGNS OF INFECTION SUCH AS PAIN, SWELLING, REDNESS DISCHARGE OR HEAT. IF THERE ARE SIGNS THAT THE SITE MAY BE INFECTED, THE PATIENT IS ADVISED TO IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE, CONTACT A HEALTHCARE PROVIDER AND TREAT THE INFECTION ACCORDING TO THE HEALTHCARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER FOLLOWED THESE INSTRUCTIONS PER THE USER GUIDE AND RECEIVED MEDICAL ATTENTION FROM HER HEALTHCARE PROVIDER IN ORDER TO TREAT THE INFECTION. IN ADDITION, THE OMNIPOD WEBSITE LISTS SKIN BARRIER PRODUCTS THAT CAN BE USED WHEN APPLYING THE POD THAT MAY HELP TO PREVENT THIS TYPE OF SKIN CONDITION FROM RECURRING.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT SHE HAS A RASH AT THE POD SITE THAT HAS BEEN GOING ON FOR MORE THAN SIX MONTHS. THE SITE GETS "RED WITH HIVES AND SOMETIMES GETS INFECTED." SHE HAD CONSULTED WITH HER HEALTHCARE PROVIDER WHO RECOMMENDED SKIN BARRIER PRODUCTS, BUT THEY "HAVE NOT HELPED." SHE HAD ALSO BEEN PLACED ON MEDICATION TO TREAT THE INFECTION. PER HER HEALTHCARE PROVIDER'S SUGGESTION, SHE MAY BE PUT ON STEROIDS. NO PRODUCT 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	UNAVAILABLE

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Other