FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3854991 · Received June 9, 2014

Report

Report Number: 2531779-2014-16131
Event Type: Malfunction
Date Received: June 9, 2014
Report Date: June 2, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
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.

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 DATE OF SUBMISSION 08/01/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE INTACT AND FREE OF DAMAGE. EVALUATION REVEALED THAT THE UP AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THIS COMPLAINT, THE DISPLAY SCREEN WAS OBSERVED TO BE DIM AND DISCOLORED.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. REPORTEDLY, THE ¿UP¿ AND ¿DOWN¿ BUTTONS WERE UNDER RESPONSIVE. IT WAS REPORTED THAT THE KEYPAD COVER WAS UNDAMAGED AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. 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
335437	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR