FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 2091492 · Received May 17, 2011

Report

Report Number: 2939301-2011-04103
Event Type: Malfunction
Date Received: May 17, 2011
Report Date: May 5, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, 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

FOLLOW-UP # 1 ((B)(4) 2011) - DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER'S LCD WAS FOUND TO BE CRACKED/BROKEN. HOWEVER, THE ALLEGED COMPLAINT OF THE METER READING INACCURATELY COULD NOT BE CONFIRMED WITH THE INVESTIGATION. 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

THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE METER DISPLAY HAS BLACK MARKS AND DISPLAYS INACCURATE HIGH READINGS. THESE ISSUES WERE 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.		3085649

Patients

Seq	Age	Sex	Outcome	Treatment
1