FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3872144 · Received June 13, 2014

Report

Report Number: 2531779-2014-16793
Event Type: Malfunction
Date Received: June 13, 2014
Report Date: May 29, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

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).

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED NO CALL SERVICE ALARM OR ANY ACTIVITY OUTSIDE OF NORMAL USE. THE PUMP WAS ABLE TO BE PAIRED WITH A TEST TRANSMITTER SUCCESSFULLY AND NO ALARMS, ERRORS OR WARNINGS OCCURRED DURING THE INVESTIGATION. THE PUMP PASSED A RADIO FREQUENCY TEST AND THERE WERE NO INTERMITTENT CONDITIONS FOUND TO THE CONTINUOUS GLUCOSE MONITORING MODULE OR TO THE PRINTED CIRCUIT BOARD. THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (DEX 90 CGM DATA FAILURE ALERT) ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE. 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
349720	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1