FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3871438 · Received June 13, 2014

Report

Report Number: 2531779-2014-16910
Event Type: Malfunction
Date Received: June 13, 2014
Report Date: June 9, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/03/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES REVEALED A CS 054 CALL SERVICE ALARM, WHICH MAY CAUSE THE DISPLAY TO BE BLANK FOR SEVERAL MINUTES, AND MULTIPLE CS 087 CALL SERVICE ALARMS IN THE ALARM HISTORIES. DURING TESTING, THE PUMP WAS POWERED ON AND EMITTED A CS 069 CALL SERVICE ALARM, INDICATING A COMPONENT FAILURE ON THE PRINTED CIRCUIT BOARD. THE BLANK SCREEN WAS NOT DUPLICATED.

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 DISPLAY (BLANK SCREEN) 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
349687	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1