FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3830340 · Received May 23, 2014

Report

Report Number: 2531779-2014-14689
Event Type: Malfunction
Date Received: May 23, 2014
Report Date: May 19, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, ALL THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE; THE CONTRAST BUTTON REQUIRED ADDITIONAL INCREASED FORCE. EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. THE KEYPAD BUTTON SYMBOLS WERE WORN WHICH HAS NO EFFECT ON INSULIN DELIVERY. 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 A KEYPAD BUTTON RESPONSE ISSUE WITH EVIDENCE OF CONTAMINATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
307475	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	31 YR