FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 1792086 · Received August 10, 2010

Report

Report Number: 2939301-2010-06418
Event Type: Malfunction
Date Received: August 10, 2010
Report Date: July 18, 2010
Manufacturer: LIFESCAN, INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, 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.

Additional Manufacturer Narrative · 1

(B)(4). 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.

Description of Event or Problem · 1

THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A LINE THROUGH 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

COVIDIEN RECEIVED A REPORT THAT A PATIENT DIED AFTER PULLING HER TRACHEOSTOMY TUBE OUT WHILE UNATTENDED. SHE WAS FOUND IN THE ROOM IN FULL ARREST. CUSTOMER STATED THAT A N-560 WAS OBSERVED TO HAVE HAD DASHES ON THE SATURATION AND PULSE-RATE DISPLAY WITHOUT AUDIBLE ALARM, AND THAT THEY DO NOT REMEMBER IF BEEP, TONE, OR INDICATOR LIGHTS WERE PRESENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1