FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 2962047 · Received January 24, 2013

Report

Report Number: 3004464228-2013-00067
Event Type: Malfunction
Date Received: January 24, 2013
Date of Event: December 28, 2012
Report Date: December 28, 2012
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 PRODUCT WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE WHETHER IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER'S GUIDE WARNS "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND ADVISES "ANY PHYSICAL STRESS CAN CAUSE YOUR BLOOD GLUCOSE TO RISE, AND ILLNESS IS A PHYSICAL STRESS. WHEN YOU ARE ILL, CHECK YOUR BLOOD GLUCOSE MORE OFTEN (AT LEAST ONCE EVERY TWO HOURS)."

Description of Event or Problem · 1

THE CUSTOMER CALLED TO REPORT ON (B)(6) 2012, SHE HAS BEEN SICK WITH A BAD COLD AND AT ABOUT 2:41 AM, HER BLOOD GLUCOSE WAS 402 MG/DL. SHE TREATED HER HIGH BG LEVEL WITH A MANUAL INJECTION (EXACT DOSAGE NOT REPORTED) WHICH BROUGHT IT DOWN TO 230 MG/DL. SHE TRIED GIVING A BOLUS (EXACT DOSAGE NOT REPORTED) WITH THE DEVICE BUT HER BG ROSE TO 311 MG/DL AND WOULD NOT COME DOWN. THE DEVICE WAS THEN DEACTIVATED AND SHE NOTICED THE CANNULA WAS BENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
34753	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L30886

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR