FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 4843143 · Received June 14, 2015

Report

Report Number: 2531779-2015-19732
Event Type: Malfunction
Date Received: June 14, 2015
Report Date: June 2, 2015
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: P130007
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

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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED MULTIPLE OCCLUSION ALARMS ASSOCIATED WITH HIGH FORCE. ON INVESTIGATION, REWIND, LOAD AND PRIME STEPS WERE SUCCESSFULLY PERFORMED WITHOUT ALARM. THE FORCE SENSOR CALIBRATION WAS EVALUATED AND FOUND TO BE DETECTING FORCE AT THE APPROPRIATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT OCCLUSION OCCURRING. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT AND THE PUMP WAS DETERMINED TO BE OPERATING AS INTENDED WITHOUT MALFUNCTION. (B)(4).

Description of Event or Problem · 1

ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (FREQUENT/PERSISTENT) 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
386886	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1