FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 1932106 · Received December 17, 2010

Report

Report Number: 2939301-2010-10833
Event Type: Malfunction
Date Received: December 17, 2010
Report Date: November 23, 2010
Manufacturer: LIFESCAN INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

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.

Additional Manufacturer Narrative · 1

THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT WAS ADMITTED WITH ACUTE CORONARY SYNDROME FOR WHICH THE CULPRIT VESSEL WAS STENTED. THE PATIENT HAD ONE EPISODE OF ANGINA DURING THE (B)(6) MONTH FOLLOW UP THAT WAS RELIEVED WITH 2 NITROGLYCERIN WITH NO FURTHER EPISODES. THERE WAS NO ANGIOGRAM PERFORMED. THE PATIENT HAD A FOLLOW-UP STRESS TEST PRIOR TO HIS 12 MONTH CLINIC VISIT, WHICH WAS NORMAL.

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 PC MESSAGE 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.		3046350

Patients

Seq	Age	Sex	Outcome	Treatment
1