FDA Adverse Event Injury Summary report: N

ANIMAS INSULIN CARTRIDGE

MDR report key: 1944390 · Received December 21, 2010

Report

Report Number: 2531779-2010-03122
Event Type: Injury
Date Received: December 21, 2010
Report Date: November 30, 2010
Manufacturer: ANIMAS CORP.
Product Code: LZG
PMA / PMN Number: K032257
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A DEVICE FROM RESERVE SAMPLE WAS EVALUATED (LOT# B201543) ON (B)(6) 2010. THE CARTRIDGE PASSED VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. IN CONCLUSION, NO DEFECTS WERE FOUND WITH THE RESERVED SAMPLE.

Description of Event or Problem · 1

THE PT'S FATHER CONTACTED ANIMAS TO REPORT THAT HE WAS CHANGING THE CARTRIDGE BECAUSE THE PT HAD A BLOOD GLUCOSE RESULT OF 600 MG/DL WITH NO SYMPTOMS OR KETONES. HE STATED HE HAD CHANGED THE INFUSION SITE WITHIN THE LAST 1-2 HOURS. THERE WERE NO REPORTED ISSUES WITH THE SITE AND CANNULA, BUT THE PT'S FATHER NOTICED A LARGE AMOUNT OF AIR BUBBLES IN CARTRIDGE AND TUBING. THE PT WAS GIVEN A CORRECTION VIA SYRINGE. THE ANIMAS REP REVIEWED TECHNIQUES ON HOW TO DECREASE AIR BUBBLES AND ADVISED THE PT'S FATHER TO CHANGE OUT THE INFUSION SET AND SITE. THE PT'S FATHER WAS ADVISED TO CALL BACK IF THE PT'S BLOOD GLUCOSE DO NOT GET RESOLVED AFTER INFUSION SITE/SET CHANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY OBTAINED A 600 MG/DL BLOOD GLUCOSE RESULT DUE TO REPORTED AIR BUBBLES IN THE TUBING AND CARTRIDGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANIMAS INSULIN CARTRIDGE	INSULIN CARTRIDGE	LZG	ANIMAS CORP.	IR 1200/1250/2020/OTP

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening