FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3881926 · Received June 18, 2014

Report

Report Number: 2531779-2014-17490
Event Type: Malfunction
Date Received: June 18, 2014
Report Date: June 16, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/16/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE TORN ABOVE THE UP ARROW BUTTON AND PEELING FROM THE TEAR. THE DOWN ARROW AND OK KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDERNEATH THE UP ARROW, DOWN ARROW AND CONTRAST BUTTONS CONTACTS. THE DAMAGED KEYPAD COVER WAS NOT MAKING PROPER CONTACT WITH THE KEYPAD CONTACTS. EVALUATION ALSO REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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. (B)(6).

Description of Event or Problem · 1

THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDERNEATH THE UP ARROW, DOWN ARROW AND CONTRAST BUTTONS CONTACTS. EVALUATION ALSO REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/16/2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357246	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	31 YR