FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3120626 · Received May 20, 2013

Report

Report Number: 2531779-2013-06737
Event Type: Malfunction
Date Received: May 20, 2013
Report Date: April 26, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS FOUND TO BE DEEPLY SCRATCHED. 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.

Additional Manufacturer Narrative · 1

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. (B)(6).

Description of Event or Problem · 1

ON (B)(6) 2013, THE DISTRIBUTER CONTACTED ANIMAS AND REPORTED LINES ON THE DISPLAY SCREEN. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS NOT BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
222172	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1