FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2080845 · Received May 6, 2011

Report

Report Number: 2531779-2011-03211
Event Type: Malfunction
Date Received: May 6, 2011
Date of Event: April 9, 2011
Report Date: April 9, 2011
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 (B)(6) 2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS:A REVIEW OF PUMP HISTORY REVEALED A LOW BATTERY WARNING DUE TO LOW VOLTAGE. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 5 HOURS WITHOUT ANY OVERHEATING OR ALARMS. THE PUMP ELECTRICAL CURRENT DRAW WAS TESTED AND CONFIRMED TO BE LESS THAN 1 A. THE PUMP WAS OPENED NO DAMAGE OR DEFECTS WERE FOUND TO THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS.

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PUMP HAD A SHORT BATTERY LIFE ISSUE (LASTED ONLY 2 DAYS) AND THE BATTERY FELT WARM. THE PUMP REPORTEDLY HAS NO PHYSICAL DAMAGE AND THE BATTERY CAP WAS SECURELY ATTACHED. THE REPORTED ISSUES WERE NOT RESOLVED WITH TROUBLESHOOTING WITH ANIMAS CUSTOMER SUPPORT. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

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	19 YR