Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT¿S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT¿S ONETOUCH PING METER¿S DISPLAY WAS FLICKERING OFF AND ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON 10/14/2014 AND OBTAINED THE FOLLOWING INFORMATION. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT APPROXIMATELY NOON. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH NOVOLOG INSULIN THROUGH PUMP THERAPY AND TESTS BETWEEN 8-12 TIMES PER DAY. THE REPORTER STATED THAT ALTHOUGH THE SUBJECT METER¿S DISPLAY WAS FLICKERING, THE METER WAS STILL ABLE TO PROVIDE RESULTS. THE REPORTER STATED THE METER READ IN THE 500¿S (MG/DL) WHICH THE REPORTER THOUGHT TO BE HIGH, SO SHE WOULD TEST THE PATIENT ON A BACKUP METER (ULTRAMINI) WHICH READ IN THE HIGH 300MG/DL RANGE. THE REPORTER CLAIMED THAT DURING THE WEEK OF (B)(6) 2014, THE PATIENT¿S BLOOD GLUCOSE BECAME VERY HIGH, HE WOULD HAVE SYMPTOMS OF THIRST AND FREQUENT URINATION AND THE SUBJECT METER RESULTS CORRELATED WITH THE HIGH READINGS. THE REPORTER STATED APPROXIMATELY 24 HOURS AFTER DEVELOPING THE HIGH BLOOD GLUCOSE SYMPTOMS; HE WAS TESTED, BY THE REPORTER, AS POSITIVE FOR KETONES USING AT HOME KETONE TESTING KIT. THE REPORTER STATED SHE CONTINUED TO TEST THE PATIENT REGULARLY WITH THE BACKUP METER AND BASED THE PATIENT¿S INSULIN DOSES ON THE RESULTS OBTAINED WITH THE BACKUP METER, AND NOT BASED ON THE PING METER RESULTS. THE REPORTER STATED SHE DOUBLED THE DOSE ON HIS NOVOLOG INSULIN AS ADVISED BY THE PATIENT¿S DOCTOR UNTIL HIS BLOOD GLUCOSE CAME BACK DOWN A FEW DAYS LATER. THE REPORTER DENIED TAKING THE PATIENT TO THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS NOT BEING USED FOR THE FIRST TIME. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. DESPITE THE DISPLAY ISSUE WITH THE SUBJECT DEVICE, THE PATIENT WAS STILL ABLE TO TEST ON THE SUBJECT METER AND OBTAIN ACTIONABLE RESULTS. THE RESULTS OBTAINED ON THE SUBJECT METER WERE CONSISTENT WITH THE PATIENT¿S SYMPTOMS. THERE WAS NO EVIDENCE IN DELAY OF TREATMENT BECAUSE THE PATIENT WAS ABLE TO USE THE SUBJECT DEVICE AS WELL AS A BACKUP METER TO CONTINUE WITH HIS DIABETES TREATMENT PLAN. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.