FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 2810042 · Received October 31, 2012

Report

Report Number: 2531779-2012-12942
Event Type: Malfunction
Date Received: October 31, 2012
Report Date: October 17, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K042873
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 11/29/2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE TORN AT THE UP ARROW BUTTON. THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED.

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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) 2012, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE UNRESPONSIVE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS COMPLAINT. 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
1	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ANM 2020 INSULIN INFUSION PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1