FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 1823246 · Received September 2, 2010

Report

Report Number: 2939301-2010-07518
Event Type: Malfunction
Date Received: September 2, 2010
Report Date: August 30, 2010
Manufacturer: LIFESCAN, INC.
Product Code: MDS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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 CRACKED/BROKEN DISPLAY. 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.

Description of Event or Problem · 1

THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A DAMAGED DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

Description of Event or Problem · 1

PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE AND TINNITUS WITH AND WITHOUT DEVICE USE AS WELL AS INTERMITTENT SWELLING AND TENDERNESS AROUND THE IMPLANT SITE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2010, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1