FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 4101626 · Received September 19, 2014

Report

Report Number: 2531779-2014-26812
Event Type: Malfunction
Date Received: September 19, 2014
Report Date: September 5, 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/04/2014 WITH THE FOLLOWING FINDINGS: THERE WERE NO CALL SERVICE (CS) 064 ALARMS OBSERVED IN PUMP HISTORY. HOWEVER, MULTIPLE ¿CS087¿ ALARMS WERE OBSERVED IN PUMP HISTORY. DURING INVESTIGATION, ¿CS69¿ ALARM WAS REPRODUCED BY APPLYING LIGHT PRESSURE ON A COMPONENT ON THE PCB. THE REPORTED CS 064 WAS UNABLE TO BE INVESTIGATED DUE TO A COMPONENT FAILURE ON THE PCB. UNRELATED TO THE COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE REDDISH AND DIM. ALSO UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED FROM THE CASE SEAL UP TO THE BUMPER GRIP. 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 064) 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
585088	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1