FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 3970483 · Received July 31, 2014

Report

Report Number: 2531779-2014-21933
Event Type: Malfunction
Date Received: July 31, 2014
Report Date: July 23, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K042873
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

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/02/2014 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 NO COSMETIC DAMAGES. THE BOTH CAPS WERE NOT RETURNED AND A TEST BATTERY CAP WAS USED IN THE EVALUATION. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. THE REPORTED DISPLAY ISSUE WAS DUPLICATED IN THE INVESTIGATION. UNRELATED TO THE DISPLAY ISSUE, THE ¿UP¿ AND ¿DOWN¿ ARROW BUTTONS RESPONDED INTERMITTENTLY AND REMOVAL OF THE KEYPAD COVER FOUND CONTAMINATION UNDER ALL THE BUTTON CONTACTS.

Description of Event or Problem · 1

ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THERE WAS PIXEL COLOR CHANGE ON THE PUMP DISPLAY. 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
447613	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1