ANIMAS INSULIN CARTRIDGE

Report

Report Number: 2531779-2013-02427
Event Type: Injury
Date Received: March 6, 2013
Date of Event: February 2, 2013
Report Date: February 4, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K032257
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. A LEAK, FILL AND FORCE TEST WERE PERFORMED WITH NO FAILURES NOTED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

Description of Event or Problem · 1

ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT ON (B)(6) 2013, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE RANGE OF 30 TO 32MMOL WITH LARGE KETONES AND WAS HOSPITALIZED FOR 4 TO 5 DAYS. THE PATIENT REPORTEDLY WAS GIVEN TEMP BASALS OF 20%, THE PATIENT'S BG WENT DOWN TO 17MMOL AND THEN WAS RELEASED FROM THE HOSPITAL. IT WAS NOTED THAT THE REPORTER WAS AGITATING THE INSULIN BY PUSHING AIR INTO THE INSULIN. THERE WERE REPORTEDLY NO ISSUES WITH THE SITE AND NO ISSUES WITH BENT CANNULAS. THIS COMPLAINT IS BEING REPORTED DUE THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BECAUSE THE PATIENT WAS NOT PRESSURING THE VIAL CORRECTLY CAUSING AIR BUBBLES TO DEVELOP IN THE CARTRIDGE. THE PATIENT REPORTEDLY HAD BEEN RECENTLY ILL AND HAD BEEN TAKING MEDICATION UNRELATED TO THE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
96351	ANIMAS INSULIN CARTRIDGE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ANM IR1200/1250/2020/OTP CART

Patients

Seq	Age	Sex	Outcome	Treatment
1	14 YR		Hospitalization\| L