FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 4227811 · Received November 5, 2014

Report

Report Number: 2531779-2014-31585
Event Type: Malfunction
Date Received: November 5, 2014
Report Date: October 21, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #1: DATE OF SUBMISSION 04/03/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/23/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED MULTIPLE CONSECUTIVE CALL SERVICE (CS054/CS052/CS012) ALARMS ON 10/09/2014; 2-¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY WITH NO ¿CS012¿ ALARMS OR ANY OTHER ERRORS, ALARMS OR WARNINGS DURING THE INVESTIGATION. THE PRODUCT PERFORMED WITHIN SPECIFICATIONS AND THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. THE PUMP¿S COVER WAS REMOVED AND THERE WAS NO INTERMITTENT CONDITION FOUND INTERNALLY. 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 FOR EVALUATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 012) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
712131	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1