FDA Adverse Event Malfunction Summary report: N

OT PING METER

MDR report key: 2843367 · Received November 23, 2012

Report

Report Number: 3008382007-2012-06613
Event Type: Malfunction
Date Received: November 23, 2012
Report Date: November 19, 2012
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: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH PING METER WAS READING INACCURATELY HIGH RESULTS COMPARED TO A CALIBRATED LAB DRAW. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE VALUE OF "214MG/DL" ON THE LFS METER AND "163MG/DL" ON THE LAB DRAW. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20MG/DL OR <=20% OBTAINED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE REPORTED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE SUBJECT METER DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT A SERIOUS INJURY OCCURRED. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT PING METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR