FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 5301135 · Received December 16, 2015

Report

Report Number: 2939301-2015-54049
Event Type: Malfunction
Date Received: December 16, 2015
Report Date: December 2, 2015
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
PMA / PMN Number: K082590
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: 003

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

THE PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2015, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE LOW CONTROL SOLUTION RESULTS. THE USER REPORTED THAT THE QUALITY CONTROL TESTS FAILED SPECIFICATION BECAUSE THE RESULTS FELL ABOVE THE SPECIFIED RANGE ON THE TEST STRIP VIAL. THE REPORTER CLAIMED OBTAINING CONTROL SOLUTION READING(S) OF "109 MG/DL" WITH THE CONTROL SOLUTION FOR THE SUBJECT LOT BEING 122-162 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT 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
830744	OT PING METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3702631

Patients

Seq	Age	Sex	Outcome	Treatment
1