FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2820724 · Received November 6, 2012

Report

Report Number: 2531779-2012-13215
Event Type: Malfunction
Date Received: November 6, 2012
Report Date: October 10, 2012
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 BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE IS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. 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. THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE BUTTON PRESSES TO ENGAGE. THE CONTRAST BUTTON WAS UNRESPONSIVE TO BUTTON PRESSES. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEYPAD CONTACTS. THE CONTRAST KEY CONTACT WAS FOUND TO BE MISALIGNED.

Description of Event or Problem · 1

THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE KEYPAD BUTTONS WERE STICKING AND REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE PATIENT DENIED ANY DAMAGE TO THE KEYPAD OR ANY EVIDENCE OF MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND CLEANED THE PUMP WITH A DAMP TISSUE. THERE IS NO ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUES.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR