FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 1911330 · Received November 23, 2010

Report

Report Number: 3004464228-2010-01383
Event Type: Malfunction
Date Received: November 23, 2010
Date of Event: August 30, 2010
Report Date: October 21, 2010
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 POD WAS THOROUGHLY EVALUATED AND NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCY WAS FOUND. THE DEVICE FUNCTIONED AS INTENDED DURING THE INVESTIGATION. AN AIR BUBBLE, HOWEVER, WAS FOUND WITHIN THE POD'S INSULIN RESERVOIR - THIS TYPICALLY OCCURS WHEN AIR IS INTRODUCED INTO THE POD DURING THE FILL PROCESS AND IS NOT RELATED TO ANY MANUFACTURING PROCESS OR PRODUCT DEFECT. THE OMNIPOD USER'S GUIDE INSTRUCTS USERS ON PROPER FILLING TECHNIQUE TO AVOID THIS CONDITION, AS FAILURE TO DO SO MAY RESULT IN UNINTENDED/INTERRUPTED INSULIN DELIVERY. BY INTRODUCING AIR INTO THE RESERVOIR, THE CUSTOMER POTENTIALLY CREATED A CONDITION THAT RESULTED IN THE DELIVERY OF AN UNINTENDED INSULIN DOSE, CAUSING THE LOW BG LEVELS AS REPORTED. "USER ERROR", THEREFORE, IS CONSIDERED TO BE A CONTRIBUTING FACTOR TO THE CUSTOMER'S LOW BG'S.

Description of Event or Problem · 1

THE REPORT INDICATED THAT THE CUSTOMER'S BG LEVELS DECREASED CONTINUOUSLY WITHIN THE FIRST DAY OF WEARING THE POD. HIS LEVELS RANGED FROM 61 MG/DL DOWN TO 35 MG/DL OVER THE FINAL 2.5 HOURS. THOUGH HE TREATED EACH LOW READING WITH A GLASS OF APPLE JUICE, HIS BG'S CONTINUED TO LOWER - NO INCREASE WAS RECORDED DURING THIS TIME. THE POD WAS FINALLY DEACTIVATED AND 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	L30339

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Other