FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 3172998 · Received May 30, 2013

Report

Report Number: 3004464228-2013-00515
Event Type: Malfunction
Date Received: May 30, 2013
Date of Event: April 30, 2013
Report Date: April 30, 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 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, "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 "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."

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT HE ACTIVATED THE DEVICE AT 7:29PM ON (B)(6). BLOOD GLUCOSE HISTORY, INSULIN TREATMENT AND CARBOHYDRATE INTAKE FOR THE POD ARE AS FOLLOWS: SEE SCANNED TABLE. AT 10:55 AM THE POD WAS DEACTIVATED AND HE OBSERVED THAT THE CANNULA WAS KINKED RIGHT IN THE MIDDLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
239850	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L30847

Patients

Seq	Age	Sex	Outcome	Treatment
1	4 YR