ACT 5DIFF RINSE

Description of Event or Problem

THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE COULTER AC T 5DIFF CP ANALYZER WAS GIVING WHITE BLOOD COUNT (WBC) *, VOTING OUT, AND GIVING NO NUMERICAL WBC RESULTS ON MULTIPLE PATIENT SAMPLES. THE CUSTOMER INDICATED THAT PATIENT # 6 SAMPLE WAS DRAWN ON (B)(6) 2013 AND WAS ANALYZED THE SAME DAY IN THE HOSPITAL LABORATORY (REFERENCE LABORATORY). THE HOSPITAL'S RESULTS WERE CONSIDERED CORRECT. THE PATIENT'S SAMPLES WAS RUN ON THE NEXT DAY ((B)(6) 2013) ON THE ACT 5DIFF CP INSTRUMENT, WHICH RECOVERED LOW COMPLETE BLOOD COUNT/DIFFERENTIAL (CBC/DIFF) RESULTS WITH AND WITHOUT THE INSTRUMENT GENERATED MESSAGES ON EACH PARAMETER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT. PATIENT SAMPLES TESTED ON THE ACT 5DIFF CP ANALYZER ON (B)(6) 2013 ARE DOCUMENTED IN MDR 1061932-2013-01169. TWO (2) MDRS ARE BEING SUBMITTED FOR THE ERRONEOUS CBC/DIFF RESULTS OBTAINED AT THIS CUSTOMER SITE: 1061932-2013-01169, 1061932-2013-01170.

Additional Manufacturer Narrative

A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED AND REPLACED APERTURE, REPLACED O-RINGS, AND WHITE BLOOD CELL (WBC) BATH. UPON FURTHER INSPECTION, THE FSE OBSERVED MUCUS LIKE SUBSTANCE ON AN OLD ELECTRODE THAT HAD JUST BEEN REMOVED. THE FSE RAN SEVERAL SAMPLES AND THE MUCUS SUBSTANCE APPEARED ON THE WBC ELECTRODE AGAIN. THE FSE DISCOVERED THE MUCUS SUBSTANCE WAS IN THE RINSE REAGENT BOTTLE. PER PHONE CONVERSATION WITH THE CUSTOMER, THE SUBJECT REAGENT HAD BEEN IN USE FOR 11 DAYS WHEN THE ISSUE WAS OBSERVED. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY; SAMPLES WERE SENT OUT FOR ANALYSIS. THE FSE DECONTAMINATED THE INSTRUMENT AND REPLACED THE RINSE REAGENT WITH A NEW BOTTLE, EXPIRATION DATE 03/20/2014, AND VERIFIED THE INSTRUMENT'S OPERATION. FAILURE MODE WAS ATTRIBUTED TO THE MUCUS LIKE SUBSTANCE PRESENT IN THE RINSE REAGENT BOTTLE. IT IS UNKNOWN HOW THE REAGENT GOT CONTAMINATED. THE ANALYZER GENERATED MESSAGES FOR SOME PARAMETERS WHICH ALERTED THE CUSTOMER TO REVIEW THE RESULTS.