FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 2990297 · Received February 7, 2013

Report

Report Number: 3004464228-2013-00103
Event Type: Malfunction
Date Received: February 7, 2013
Date of Event: January 8, 2013
Report Date: January 11, 2013
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K042792
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA," AND 'LOW' OR 'HIGH' BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH." IT ADVISES, "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4 - 6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED."

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT AFTER WEARING THE POD ON HIS THIGH FOR ABOUT 48 HOURS, HIS BLOOD GLUCOSE READ "HIGH" (> 500 MG/DL). THE POD WAS REMOVED AND THE CANNULA WAS KINKED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
53124	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L30926

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR