FDA Adverse Event Malfunction Summary report: N

OT PING ENHANCED METER

MDR report key: 4810137 · Received June 2, 2015

Report

Report Number: 2939301-2015-22171
Event Type: Malfunction
Date Received: June 2, 2015
Report Date: May 20, 2015
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: 003

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.

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1: DEVICE EVALUATION. THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

Description of Event or Problem · 1

ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING FADING DISPLAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
354094	OT PING ENHANCED METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3745054

Patients

Seq	Age	Sex	Outcome	Treatment
1