FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2100001 · Received May 23, 2011

Report

Report Number: 2531779-2011-03640
Event Type: Malfunction
Date Received: May 23, 2011
Report Date: April 27, 2011
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1, DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED AS EXPECTED. THERE WAS NO PHYSICAL DAMAGE TO THE KEYPAD. NO DEFECT WAS FOUND ON INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. DHR REVIEW: DATE OF MANUFACTURE: 2010-03, SOFTWARE VERSION/REVISION: E3A, WITHIN SPECIFICATIONS WHEN RELEASED: YES, DISCREPANCIES IDENTIFIED: NO, COMMENTS: NO.

Additional Manufacturer Narrative · 1

AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

Description of Event or Problem · 1

THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED KEYPAD MALFUNCTION. KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THERE WAS NO REPORT OF PRODUCT MISUSE. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

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	10 YR