Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN AT APPROXIMATELY 5:47PM ON THE SAME DAY SHE CONTACTED LFS FOR ASSISTANCE. THE PATIENT FIRST TESTED AND OBTAINED A VALUE OF "64MG/DL" ON THE SUBJECT METER. THE REPORTER GAVE THE PATIENT 14GRAMS OF SUGAR AND RETESTED THE PATIENT APPROXIMATELY 15 MINUTES LATER AND OBSERVED THE FOLLOWING VALUES, "129, 142, 436 MG/DL." BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE REPORTER CLAIMED THAT APPROXIMATELY 1-2 MINUTES PRIOR TO RETESTING AFTER HAVING THE SUGAR HE BECAME "HYPERACTIVE, TALKATIVE AND RESTLESS." THE PATIENT MANAGES HIS DIABETES AN UNKNOWN TYPE OF INSULIN THROUGH PUMP THERAPY AND THE REPORTER STATED SHE ADMINISTERED 1.71 UNITS OF HUMALOG INSULIN TO THE PATIENT AT APPROXIMATELY 5:49PM. NO OTHER FORM OF TREATMENT WAS ADMINISTERED AND NO OTHER DEVICE WAS USED FOR TESTING. 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 BECAUSE THE REPORTER DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. 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 AN ADVERSE EVENT. THE PATIENT'S SYMPTOMS DO NOT MEET THE CRITERIA FOR A SERIOUS INJURY AND THE REPORTER DID NOT ADMINISTER INAPPROPRIATE TREATMENT BASED ON THE METER RESULTS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT DEVICE DID NOT MEET LFS CRITERIA FOR ACCURACY/PRECISION.