FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 5290917 · Received December 11, 2015

Report

Report Number: 3004464228-2015-02572
Event Type: Malfunction
Date Received: December 11, 2015
Date of Event: January 24, 2015
Report Date: January 24, 2015
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K122953
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR DIABETIC KETOACIDOSIS. NO RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT NUMBER WAS NOT PROVIDED. THE OMNIPOD¿S USER GUIDE WARNS TO "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 ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." IT 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

THE CUSTOMER REPORTED HIS BLOOD GLUCOSE (BG) REACHED 315MG/DL AND WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS (DKA) AFTER WEARING THE POD FOR LONGER THAN 48 HOURS. THE POD WAS DEACTIVATED AND THE PATIENT WAS TREATED WITH FLUIDS AND AN IV.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
820561	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	14000

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR		Hospitalization