FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 2885138 · Received December 26, 2012

Report

Report Number: 2531779-2012-15004
Event Type: Malfunction
Date Received: December 26, 2012
Report Date: December 5, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K042873
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6)2015 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE PUMP SHOWED THAT THE KEYPAD COVER WAS INTACT. DURING TESTING, THE CONTRAST BUTTON WAS INTERMITTENTLY UNRESPONSIVE, WHICH HAS NO EFFECT ON INSULIN DELIVERY. ALL OTHER BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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.

Description of Event or Problem · 1

THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 AND STATED THE KEYPAD BUTTONS WERE STIFF AND STICKING. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD RESPONSE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ANM 2020 INSULIN INFUSION PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR