AU680 CLINICAL CHEMISTRY ANALYZER

Description of Event or Problem

THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW, NEGATIVE PHOSPHORUS (PHOS) RESULTS FOR MULTIPLE PATIENT SAMPLES INVOLVING THE AU680 CLINICAL CHEMISTRY ANALYZER. ALL ERRONEOUSLY LOW RESULTS GENERATED ERROR FLAGS THAT IDENTIFIED THE RESULTS AS BELOW THE ANALYTICAL RANGE OF THE ASSAY. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. WHILE MOST PATIENTS HAD NO CHANGE TO TREATMENT, THIS MDR REPORTS THE EVENT FOR ONE PATIENT THAT WAS TREATED FOR THE LOW PHOS WITH IV (INTRAVENOUS) DOSE OF PHOS. CUSTOMER INDICATED THAT CONTROLS (QC) BEFORE THE EVENT WERE WITHIN FACILITY ESTABLISHED RANGES, BUT QC RESULTS AFTER THE EVENT ALSO DEMONSTRATED THE NEGATIVE, LOW RESULTS AND WERE OUT OF FACILITY RANGES. CUSTOMER REPEATED ALL SAMPLES AFTER TROUBLESHOOTING AND ISSUED CORRECTED REPORTS. THERE HAS BEEN NO REPORT OF ANY ADVERSE CONSEQUENCES NOTED FOR THE PATIENT TREATED FOR THE LOW PHOS RESULTS.

Additional Manufacturer Narrative

BECKMAN COULTER CUSTOMER SERVICE TECHNICIAN (CTS) INSTRUCTED CUSTOMER TO VERIFY THAT THE PHOSPHORUS REAGENT BOTTLES WERE PROPERLY SEATED OR SUPPORTED IN THE REFRIGERATED REAGENT COMPARTMENT. CUSTOMER FOUND THAT THE REAGENT BOTTLES WERE LEANING AND NOT SECURED. CUSTOMER PROPERLY SECURED THE REAGENT, PERFORMED ACCEPTABLE CALIBRATION AND QUALITY CONTROL RECOVERY WAS WITHIN THE FACILITY'S RANGES. NO FURTHER ISSUES HAVE BEEN REPORTED. NO HARDWARE COMPONENTS WERE REPLACED. (B)(4).