FDA Adverse Event Injury Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 2953873 · Received February 1, 2013

Report

Report Number: 3004464228-2013-00082
Event Type: Injury
Date Received: February 1, 2013
Date of Event: January 3, 2013
Report Date: January 3, 2013
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K042792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE PATIENT'S DIABETIC KETOACIDOSIS AND HOSPITALIZATION. 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 ADVISES "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS."

Description of Event or Problem · 1

A DOCTOR AT (B)(6) HOSPITAL IS CALLING TO REPORT HIS PATIENT IS HOSPITALIZED WITH KETOACIDOSIS FOR THE SECOND TIME. AT 11:34 AM HER BLOOD GLUCOSE MEASURED 454 MG/DL AND SHE CORRECTED WITH A 4.4 UNIT BOLUS. SHE TOOK A BOLUS OF 2.45 UNITS AT 12:31 PM WITH BG OF 468 MG/DL AND ANOTHER OF 3.0 UNITS AT 12:57 PM (NO BG RESULT). AT 1:57 PM HER BG WAS 496 MG/DL AND THE DOCTOR REMOVED THE POD. HE SAID THE CANNULA WAS KINKED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
43573	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	11200	L30973

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Hospitalization