FDA Adverse Event Malfunction Summary report: N

OT PING ENHANCED METER

MDR report key: 5103186 · Received September 25, 2015

Report

Report Number
2939301-2015-40602
Event Type
Malfunction
Date Received
September 25, 2015
Report Date
September 3, 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
PATIENT

Narratives

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
636383 OT PING ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

Patients

Seq Age Sex Outcome Treatment
1 44 YR