Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH PING METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT APPROXIMATELY 1:40PM. HE TESTED BACK TO BACK ON THE SUBJECT METER AND OBSERVED VALUES OF ¿161, 529, 221, 420, 246, 268 MG/DL¿ PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT ALSO CLAIMED THESE READINGS WERE HIGHER THAN HIS USUAL READINGS. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT MANAGES HIS DIABETES WITH AN UNKNOWN TYPE OF INSULIN THROUGH PUMP THERAPY AND HE DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 2 HOURS AFTER TESTING, HE CLAIMED HE DEVELOPED SYMPTOMS OF ¿WEAKNESS, CLAMMINESS AND LIGHT HEADEDNESS¿ WHICH HE ASSOCIATED WITH LOW BLOOD GLUCOSE. HE REPORTEDLY SELF TREATED HIS SYMPTOMS BY DRINKING ORANGE JUICE. 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 SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.