Description of Event or Problem · 1
A CUSTOMER COMPLAINT WAS RECEIVED FROM A EUROPEAN DISTRIBUTOR OF THE CARDIOCHEK SYSTEM REGARDING AN UNDER-RECOVERY OF CHOLESTEROL AND GLUCOSE IN THE PT'S PANELS CHOLESTEROL +HDL + GLUCOSE TEST STRIPS (LOT I904) BASED ON OBSERVATION MADE USING A THIRD PARTY LIQUID QUALITY CONTROL SOLUTION. THERE WAS NEITHER SUBMISSION OF CUSTOMER OR PATIENT DATA NOR ANY PRESUMED FAILURE IN THE FIELD. THE DISTRIBUTOR FAILED TO RETURN ANY MATERIAL FOR THE COMPLAINT INVESTIGATION. AN INTERNAL INVESTIGATION WAS UNDERTAKEN TO UNDERSTAND THIS COMPLAINT REPORT AND THAT REVEALED, USING RETAINED MATERIALS FROM THE SAME LOT, THAT ALL THREE ANALYTES WERE UNDER-RECOVERING WHEN COMPARED TO A REFERENCE STANDARD METHOD. ONLY ONE PRIOR REPORT OF UNDER-RECOVERY, SPECIFICALLY FOR THE HDL ANALYTE HAD BEEN RECEIVED AND THIS WAS NOT ABLE TO BE CONFIRMED FOR THIS LOT, WHICH CONSISTED OF MORE THAN 87,000 DISTRIBUTED STRIPS. THE PRODUCT EXPIRATION DATE IS 5-OCTOBER 2010. USING A HEALTH - MEDICAL RISK EVALUATION (FDA GUIDANCE "MANAGING RECALLS FOR COMPLIANCE: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS"), THE LOSS OF RECOVERABLE CHOLESTEROL AND HDL IS A MANAGEABLE TO TOLERABLE HEALTH RISK. CONVERSELY A LOSS OF RECOVERABLE GLUCOSE IS A MANAGEABLE TO MODERATE HEALTH RISK BASED ON THE FREQUENCY OF THE OCCURRENCE AND THE PRESUMED SEVERITY. BASED ON THE CURRENT DATA AND THE OBSERVED LOW FREQUENCY OF UNDER-RECOVERY IT IS CLEAR THAT THE CHOLESTEROL AND HDL PRESENT NO HEALTH RISK, WHILE GLUCOSE UNDER-RECOVERY, WHICH IS NOT AS SIGNIFICANT AS THE CHOLESTEROL AND HDL UNDER-RECOVERY, DOES PRESENT A LOW TO MODERATE HEALTH RISK, SINCE GLUCOSE IS A CRITICAL ANALYTE. THUS THIS LOT IS BEING RECOVERED FROM THE FIELD. ROOT CAUSE ANALYSIS IS UNDERWAY AND IS FOCUSING ON A LOSS OF STABILITY OF SPECIFIC REAGENTS, WHICH IS LOT SPECIFIC, BASED ON PRODUCT SURVEILLANCE. WE HAVE SUBMITTED THIS MEDICAL DEVICE REPORT TO ALERT USERS OF THIS LOT NUMBER WHILE THE EVALUATION CONTINUES AND THE FIELD NOTIFICATION COMMENCES.