FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 2924513 · Received January 22, 2013

Report

Report Number: 2531779-2013-00963
Event Type: Malfunction
Date Received: January 22, 2013
Report Date: January 1, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE OK, AND UP AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ENGAGE. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

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

ON (B)(4) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT THE OK KEYPAD BUTTON WAS UNRESPONSIVE. THE OK KEYPAD BUTTON SYMBOL WAS REPORTEDLY WORN. THE PATIENT DENIED DAMAGE TO THE KEYPAD AND ALSO DENIED THAT THE PUMP WAS EXPOSED TO MOISTURE. THE PATIENT REPORTEDLY WORE THE PUMP UNDERNEATH CLOTHING ATTACHED TO CLIP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
31392	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ANIMAS VIBE INSULIN PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1	29 YR