FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN MANAGEMENT SYSTEM

MDR report key: 8685340 · Received June 10, 2019

Report

Report Number: 3004464228-2019-05120
Event Type: Malfunction
Date Received: June 10, 2019
Date of Event: May 23, 2019
Report Date: May 23, 2019
Manufacturer: INSULET CORPORATION
Product Code: LZG
UDI-DI: 20385081120033
PMA / PMN Number: K162296
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: UST400. 17845-5A-AW REV B 09/17. CHECKING YOUR BLOOD GLUCOSE. CHAPTER 4 / PAGE 36. WARNINGS: TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 115), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 301 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT DRANK WATER AND BOLUSED. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY ARE AS FOLLOWS: (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
478155	OMNIPOD INSULIN MANAGEMENT SYSTEM	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	19191	L44551	20385081120033

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR