FDA Adverse Event Malfunction Summary report: N

INSULIN INFUSION PUMP

MDR report key: 3895714 · Received June 25, 2014

Report

Report Number: 2531779-2014-18307
Event Type: Malfunction
Date Received: June 25, 2014
Report Date: June 21, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2014. THE PUMP SERIAL # WAS ORIGINALLY REPORTED AS (B)(4). THE CORRECT SERIAL # IS (B)(4).

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/17/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUES WERE FOUND WITH THE BUTTONS. A LEAK TEST SHOWED A LEAK ON THE DISPLAY LENS. PUMP CASING WAS OPENED AND EVIDENCE OF MOISTURE CORROSION WAS FOUND INSIDE THE PUMP.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT MOISTURE WAS OBSERVED BEHIND THE DISPLAY WITH NO DAMAGE TO THE PUMP NOTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISUE 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
371562		INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR