FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3811744 · Received May 15, 2014

Report

Report Number: 2531779-2014-13657
Event Type: Malfunction
Date Received: May 15, 2014
Report Date: May 1, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 07/09/2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THERE WAS EVIDENCE OF MOISTURE ON THE DISPLAY SCREEN; HOWEVER, NO VISIBLE MOISTURE BEHIND THE DISPLAY LENS, NO CRACKS OR DAMAGE VISIBLE ON THE PUMP CASE, NO VISIBLE CORROSION IN THE BATTERY OR CARTRIDGE COMPARTMENTS. A LEAK TEST WAS PERFORMED AND REVEALED A LEAK AT THE DISPLAY LENS. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE RESIDUE PRESENT ON THE INTERNAL COMPONENTS OF THE PUMP AND THE PRINTED CIRCUIT BOARD.

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 CASING/CONDITION (MOISTURE INGRESS) 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
290811	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	5 YR