FDA Adverse Event Malfunction Summary report: N

OT ULTRALINK METER

MDR report key: 3974482 · Received August 3, 2014

Report

Report Number: 2939301-2014-19448
Event Type: Malfunction
Date Received: August 3, 2014
Report Date: July 29, 2014
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
PMA / PMN Number: K073231
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, 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

FOLLOW-UP # 1 ¿ (12/03/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 8/7/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/21/2014 WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT HAD NO TESTING PERFORMED AS CUSTOMER STATED HE USED THE INCORRECT CONTROL SOLUTION. 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

ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY LOW CONTROL SOLUTION RESULTS. THE REPORTER WAS UNABLE TO RECALL THE SPECIFIC RESULTS OBTAINED ON THE SUBJECT METER (ONETOUCH ULTRALINK). THIS COMPLAINT IS BEING REPORTED BECAUSE IT IS NOT KNOWN IF THE REPORTED RESULTS MEET LIFESCAN¿S ACCURACY CRITERIA AND THE ALLEGED INACCURACY 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
452646	OT ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3650480

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR