FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3890534 · Received June 24, 2014

Report

Report Number: 2531779-2014-18075
Event Type: Malfunction
Date Received: June 24, 2014
Report Date: June 16, 2014
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 ON 08/14/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION CONFIRMED THAT THE BATTERY COMPARTMENT WAS CRACKED AT THE OPENING OF THE BATTERY CHAMBER. NO BATTERY CAP WAS RETURNED WITH THE PUMP. A TEST BATTERY CAP WAS ABLE TO BE FULLY SECURED TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. THERE WERE NO POWER ISSUES OBSERVED DURING INVESTIGATION. THERE WAS NO EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT. 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 CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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
367803	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1