FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3760403 · Received April 21, 2014

Report

Report Number: 2531779-2014-10606
Event Type: Malfunction
Date Received: April 21, 2014
Date of Event: March 18, 2014
Report Date: April 2, 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

FOLLOW-UP # 1 DATE OF SUBMISSION 07/11/2014-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/25/2014 WITH THE FOLLOWING FINDINGS:A VISUAL INSPECTION OF THE PUMP CONFIRMED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN ON TO THE PUMP WITH NO POWER LOSS. NO EVIDENCE OF MOISTURE DAMAGE WAS FOUND IN THE COMPARTMENT. UNRELATED TO THE COMPLAINT, THE AUDIO BOLUS BUTTON COVER AND PLUG WERE DETACHED FROM THE PUMP; EXPOSING THE BUTTON CONTACT. THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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 DISTRIBUTOR CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE PUMP¿S BATTERY COMPARTMENT WAS DAMAGED. 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
240579	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1