Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/PATIENT'S SPOUSE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT OR REPORTER FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT APPROXIMATELY 5:15PM. JUST PRIOR TO THE ALLEGED ISSUE, THE PATIENT WAS REPORTEDLY "NON RESPONSIVE, HIS EYES WERE GLAZED OVER." THE REPORTER TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT DEVICE AND OBSERVED VALUES OF "42, 62, AND 101" (MG/DL). IT IS NOT KNOWN WHETHER ANY TYPE OF INTERVENTION WAS ADMINISTERED IN BETWEEN TESTING. BASED ON THE PATIENT'S SYMPTOMS, THE REPORTER FELT THE READINGS WERE HIGHER THAN EXPECTED. THE PATIENT MANAGES HIS DIABETES WITH INSULIN THROUGH PUMP THERAPY (UNKNOWN TYPE AND DOSE) AND IN RESPONSE TO THE ALLEGED ISSUE; SHE GAVE HIM/ATTEMPTED TO GIVE HIM UNKNOWN FOOD/DRINK AT BETWEEN 5:15-5:45PM AND CONTACTED EMERGENCY MEDICAL SERVICES (EMS). WHEN THE EMS ARRIVED, THEY TESTED THE PATIENT ON THEIR DEVICE (UNKNOWN METER) AND REPORTEDLY OBSERVED A VALUE OF "23MG/DL" AT APPROXIMATELY 5:45PM. THE TESTS BETWEEN THE SUBJECT DEVICE AND THE EMS METER WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. AT 5:45PM, THE PATIENT WAS TREATED BY EMS WITH A GLUCAGON INJECTION. IT IS NOT KNOWN IF THE PATIENT WAS TAKEN TO THE HOSPITAL. IT IS ALSO NOT KNOWN WHAT THE PATIENT'S PRIOR BLOOD GLUCOSE READINGS WERE AND WHAT ACTIONS HE TOOK IN RESPONSE TO THE EARLIER RESULT(S).AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE AND THE TESTING TECHNIQUE WAS CORRECT. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. ALTHOUGH THE PATIENT WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT HAD BECOME SYMPTOMATIC PRIOR TO OBTAINING THE ALLEGED INACCURATE RESULT. IN ADDITION, THERE IS NO EVIDENCE OF DELAY IN TREATMENT AS A RESULT OF THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE RESULT(S) OBTAINED WITH THE SUBJECT DEVICE DID NOT CORRELATE TO THE PATIENT'S SYMPTOMS, FORM OF TREATMENT OR RESULT OBTAINED ON THE HCP DEVICE.