FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3852586 · Received June 5, 2014

Report

Report Number: 2531779-2014-16050
Event Type: Malfunction
Date Received: June 5, 2014
Report Date: May 31, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 07/18/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/09/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE PEELING FROM THE BOTTOM TO THE CONTRAST BUTTON AND WAS ALSO TORN AT THE OK BUTTON. DURING TESTING, ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. THE UP ARROW AND OK BUTTON CONTACTS WERE FOUND TO BE INVERTED.

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.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (DAMAGE PRIOR TO TACTILE CHANGE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE. IT WAS NOTED THAT THE KEYPAD COVER WAS DAMAGED. 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
329812	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR