OT PING METER

MDR report key: 2312878 · Received October 28, 2011

Report

Report Number: 2939301-2011-10698
Event Type: Malfunction
Date Received: October 28, 2011
Report Date: October 21, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(SERIAL #) INFORMATION WAS NOT PROVIDED. TEST STRIP LOT #: NOT PROVIDED. THE 510(K) # IS K080639.

Description of Event or Problem · 1

ON (B)(6) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS DISPLAYING THE APPLY SAMPLE MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT'S MOTHER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 7PM. ACCORDING TO THE PATIENT'S MOTHER, AT THE SAME TIME PRIOR TO THE START OF THE REPORTED METER ISSUE THE PATIENT WAS FEELING CONFUSED, DISORIENTED, AND AGITATED. THE PATIENT'S MOTHER, HOWEVER, DENIED THE PATIENT RECEIVED ANY FORM OF MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE BEGAN. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT'S MOTHER DID NOT HAVE THE PATIENT'S TESTING SUPPLIES AVAILABLE. THE CSR CONFIRMED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

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