FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2366442 · Received December 12, 2011

Report

Report Number: 2531779-2011-09186
Event Type: Malfunction
Date Received: December 12, 2011
Report Date: November 16, 2011
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT BUT THE KEYPAD SYMBOLS WERE WORN; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. 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.

Description of Event or Problem · 1

THE REPORTER STATED THAT ALL OF THE KEYPAD BUTTONS HAD A DELAYED RESPONSE FOR THE PAST SIX WEEKS AND REQUIRED SEVERAL PRESSES ON THE KEYPAD IN ORDER TO ELICIT A RESPONSE. THE REPORTER ALSO STATED THAT THE DOWN ARROW BUTTON HAD NORMAL SPRING BACK BUT REQUIRED HARD PRESSES IN ORDER FOR IT TO RESPOND. THE PUMP WAS REPORTEDLY CLEANED WITH WATER USING A SOFT DAMP CLOTH OR Q-TIP.

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	15 YR