FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1150111 · Received August 29, 2008

Report

Report Number: 3004464228-2008-00197
Event Type: Malfunction
Date Received: August 29, 2008
Date of Event: August 11, 2008
Report Date: August 11, 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 EVALUATION INDICATES 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 A DISTINCT "CRACKLING" 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 REPORT THAT SHE DID NOT THINK HER POD WAS DELIVERING INSULIN. CUSTOMER DID NOT HAVE MANY DETAILS. CUSTOMER CHANGED HER POD AND HER BLOOD SUGAR WENT UP TO 488MG/DL. SHE STOPPED THIS POD AND STARTED A NEW ONE. NO FURTHER INFORMATION AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L11694

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other