FDA Adverse Event Malfunction Summary report: N

OMNIPOD INFUSION PUMP

MDR report key: 2982238 · Received December 8, 2008

Report

Report Number: 3004464228-2008-00339
Event Type: Malfunction
Date Received: December 8, 2008
Date of Event: November 12, 2008
Report Date: November 12, 2008
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K042792
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS RETURNED AND EVALUATED. THE EVAL INDICATE A PROBABLE PROBLEM WITH THE RETAINER THAT ALLOWED A COMPONENT TO MOVE RESULTING IN DAMAGE. THIS DAMAGE PREVENTED THE PLUNGER FROM ADVANCING. THE USER WOULD HAVE BEEN AWARE OF A PROBLEM DURING THE FILL PROCESS. THERE IS RESISTANCE FELT IN FILLING THE POD WITH INSULIN AND DISTINCT "CRACKING" NOISE RESULTING FROM STRIPPING THE THREADS OF THE COMPONENT WHEN OVER-PRESSURIZED. THE OMNIPOD USER GUIDE STATES: "WARNING NEVER USE A POD IF, DURING FILL, YOU DETECT ANY CRACKLING NOISE OR RESISTANCE WHILE DEPRESSING THE PLUNGER OF THE FILL SYRINGE. USING A POD WITH THESE CONDITIONS COULD RESULT IN UNDER-DELIVERY OF INSULIN." THE USER IS ALSO INSTRUCTED IN THE USER GUIDE TO MONITOR BLOOD GLUCOSE LEVELS FREQUENTLY. BY FOLLOWING THESE RECOMMENDATIONS, THE USER BECAME AWARE OF THEIR HIGH BLOOD GLUCOSE AND STARTED A NEW POD OR BACKUP THERAPY IF NEEDED.

Description of Event or Problem · 1

CUSTOMER CALLED TO SAY HE STARTED A POD IN THE MORNING AROUND 8:00AM AND HIS BLOOD GLUCOSE (BG) LEVELS HAVE BEEN ELEVATED SINCE. HIS BG LEVELS RANGED BETWEEN 90-380 MG/DL BEFORE TAKING THE POD OFF AND STARTING A NEW ONE. NO FURTHER ISSUES WERE IDENTIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OMNIPOD INFUSION PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L11814

Patients

Seq	Age	Sex	Outcome	Treatment
1	24 YR		Other