ONETOUCHPING GLUCOSEMGMTSYSTEM

Report

Report Number: 2531779-2011-04826
Date Received: July 12, 2011
Report Date: June 8, 2011
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Additional Manufacturer Narrative · 1

BRAND NAME: ANIMAS INSULIN CARTRIDGE, TYPE OF DEVICE: INSULIN INFUSION PUMP CARTRIDGE. MODEL # IR 1200/1250/2020/OTP, CATALOG # 100-124-01, LOT # UNKNOWN. PMA/510K: K032257.

Description of Event or Problem · 1

A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) AS HIGH AS 600 MG/DL RECENTLY. A SPECIFIC DATE FOR THE BG EXCURSION WAS NOT GIVEN. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. SHE STATED THAT SHE TREATED WITH A CORRECTION INJECTION, AND THE PATIENT'S BG RESOLVED TO 150 MG/DL. THE FAMILY MEMBER REPORTED THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE AND THE TUBING AFTER PERFORMING A SITE/SET CHANGE; SHE STATED THAT SHE DID NOT PERFORM A CARTRIDGE CHANGE AT THAT TIME. SHE REPORTED THAT THE CANNULA WAS BENT. CUSTOMER SUPPORT REVIEWED TECHNIQUE WITH THE FAMILY MEMBER FOR SITE CHANGE AND FILLING THE CARTRIDGE, AND FOUND THAT USE ERROR WITH TECHNIQUE ISSUES CONTRIBUTED TO THE PATIENT'S BG EXCURSION. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ONETOUCH PING INSULIN PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 YR		Required Intervention