Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY LOW. ON (B)(6) 2013 THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 11 AM. HE INFORMED THE CCA THAT HE WOKE UP WITH SYMPTOMS OF "STOMACH PAINS, VOMITING AND SKIN SENSITIVE." HE STATED HE IMMEDIATELY TESTED WITH THE SUBJECT METER AND OBSERVED A READING OF "180 MG/DL." THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH NOVOLOG INSULIN THROUGH PUMP THERAPY; IT IS UNCLEAR WHETHER THE PATIENT MADE ANY IMMEDIATE ADJUSTMENTS TO HIS INSULIN OR OTHER DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE READING. THE PATIENT REPORTED THAT HE WENT TO THE EMERGENCY ROOM (ER) AND WAS TESTED AT THE ER WITH AN ACCUCHEK METER THAT REPORTED A VALUE OF ">300 MG/DL." THE PATIENT CLAIMED THE TIME DIFFERENCE BETWEEN THE TWO TESTS WAS WITHIN 30 MINUTES. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT WAS REPORTEDLY TREATED AT THE ER AT APPROXIMATELY 2:00PM WITH IV FLUIDS AND INSULIN, 2-3 UNITS OF BOLUS AND A 10% INCREASE IN HIS BASAL RATE. IT IS UNKNOWN IF THE PATIENT WAS RELEASED THAT SAME DAY. 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. THE TESTING TECHNIQUE WAS CORRECT. A CONTROL SOLUTION TEST WAS NOT PERFORMED AS THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. IT WAS NOTED THAT THE SUBJECT DEVICE WAS PREVIOUSLY REPLACED FOR A POWER ISSUE; ALTHOUGH THE DEVICE WAS REQUESTED BACK AT THE TIME OF THE COMPLAINT, THE PATIENT CONTINUED TO USE IT. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS HE OBTAINED AN INACCURATE READING ON THE SUBJECT METER, WHICH RESULTS IN HIM REQUIRING MEDICAL INTERVENTION FROM AT HCP AFTER THE ALLEGED METER ISSUE BEGAN.