FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2770512 · Received October 3, 2012

Report

Report Number: 2531779-2012-11720
Event Type: Malfunction
Date Received: October 3, 2012
Report Date: September 24, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

Additional Manufacturer Narrative · 1

(B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING WAS OBSERVED. DURING TESTING, ALL THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL BUTTON CONTACTS.

Description of Event or Problem · 1

THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE STICKING. THE REPORTER NOTED THAT THE KEYPAD BUTTON SYMBOLS WERE WORN OFF. THE REPORTER DENIED ANY DAMAGE TO THE KEYPAD OR EVIDENCE OF MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP ON A BELT AND DID NOT CLEAN THE PUMP. THERE IS NO ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUE.

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	12 YR