FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 1820331 · Received August 30, 2010

Report

Report Number: 2939301-2010-07304
Event Type: Malfunction
Date Received: August 30, 2010
Report Date: August 18, 2010
Manufacturer: LIFESCAN, INC.
Product Code: MDS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, 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

IT WAS REPORTED THAT BEDS PRESENT AUTOMATIC ACTIVATION OF THE ENGINE OF FEET, WITHOUT PRESSING THE COMMANDS OF THE SIDE RAILS, THE PROBLEM IS GENERATED BY CONDUCTIVITY IN THE CONNECTOR LEFT RAIL OF PT. NO INJURY REPORTED. "WE DID MEASURE BETWEEN PIN 8 AND 7 (THIGH UP), THEY PRESENT CONTINUITY IN EVERY MOMENT. WE REMOVED THE SILICON PRESENT ON THE CONNECTOR AND THE PROBLEMS FIXED." IF YOU WANT MORE INFO, WE HAVE PICTURES AND VIDEOS WITH THE PROBLEM.

Description of Event or Problem · 1

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

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT PING METER	GLUCOSE MONITORING SYS/KIT	MDS	LIFESCAN, INC.		2947214

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR