FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 3061824 · Received March 28, 2013

Report

Report Number: 3004464228-2013-00265
Event Type: Malfunction
Date Received: March 28, 2013
Date of Event: February 26, 2013
Report Date: February 26, 2013
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K042792
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO ASSESS THE PRODUCT CONDITION. THE CUSTOMER REPORTED THAT THE CANNULA WAS NOT PROPERLY INSERTED IN THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. THE OMNIPOD'S USER GUIDE WARNS "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HRS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." AND "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." QUALIFICATION RECORDS WERE REVIEWED AND PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WAS 85 MG/DL ON (B)(6) 2013 (NO TIME REPORTED), BUT STARTED TO GO UP AFTER THAT. IT REACHED 347 MG/DL AT 5:37 PM ON (B)(6). HER HUSBAND CHECKED THE POD AND NOTED THAT THE CANNULA WAS NOT IN THE BODY. AFTER TAKING THE POD OFF THE CANNULA WAS "ALL CURLED UP."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
129153	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L31063

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR