FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 1912150 · Received December 2, 2010

Report

Report Number: 2939301-2010-10427
Event Type: Malfunction
Date Received: December 2, 2010
Report Date: November 16, 2010
Manufacturer: LIFESCAN INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/21/2010. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE BATTERY CONTACT CORRODED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

Additional Manufacturer Narrative · 1

LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT; 510(K)# IS K082590.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT THE DEVICE HAD THE WRENCH ICON ILLUMINATED. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT SHOWED THE SERVICE WRENCH AND THE "CALL SERVICE" MESSAGE. THE DEVICE LOCKED UP AND WAS NOT AVAILABLE TO PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

Description of Event or Problem · 1

THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE METER REVERTING TO SETUP MODE WAS NOT RESOLVED WITH TROUBLESHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT PING METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN INC.		3062505

Patients

Seq	Age	Sex	Outcome	Treatment
1