NEG URINE COMBO 61

Description of Event or Problem

IT WAS REPORTED THAT (B)(6) SURVEY ISOLATE WAS IDENTIFIED AS LEMINORELLA SPECIES WHEN TESTED USING NEG URINE COMBO 61 (NUC61) PANELS (B)(6) 2015). CUSTOMER REPEATED THE TEST ON ANOTHER DATE AND RECEIVED THE SAME IDENTIFICATION AND BIOTYPE NUMBER 41000002. CUSTOMER REPEATED THE SPECIMEN BECAUSE THE IDENTIFICATION WAS RARE AND NOT KNOWN. THE CORRECT ID OF THE ISOLATE WAS SHIGELLA BOYDII (B)(6) BACTERIOLOGY PARTICIPANT SUMMARY REPORT. THE CUSTOMER ALSO RAN THE SAME ISOLATE ON REMEL RAPID 1 KIT (DIFFERENT MANUFACTURER) AND RECOVERED THE IDENTIFICATION OF SHIGELLA ON (B)(6) 2015 AND ON REPEAT TEST PERFORMED ON (B)(6) 2015.

Additional Manufacturer Narrative

THE MANUFACTURER PARTICIPATED IN THE SAME PROFICIENCY SURVEY USING (B)(6) ISOLATE. WHEN TESTED ON CONVENTIONAL OVERNIGHT PANELS AND READ ON THE WA INSTRUMENT, AN ID OF LEMINORELLA SP. 93.14% WAS ATTAINED. WHEN THE SAME PANEL WAS READ ON THE AUTOSCAN-4 (AS-4) INSTRUMENT, AN ID OF SHIGELLA SP. 99.30% WAS ATTAINED. THE DIFFERENCE BETWEEN THE TWO READS WAS THE CF8 (CEPHALOTHIN 8 (G/ML) WELL; THE CF8 WELL WAS NEGATIVE ON THE WA AND POSITIVE ON THE AS-4. IT WAS NOTED THAT THE CF8 WELL WAS A WEAK POSITIVE WHEN VISUALLY VERIFIED. THE RESULTS FROM THE CF8 PANEL ALONG WITH THE PANEL RESULTS FROM THE OTHER BIOCHEMICALS/ANTIMICROBICS ARE USED TO GENERATE THE BIOTYPE NUMBER FOR THE ORGANISM TESTED AND THE CORRESPONDING IDENTIFICATION. AN ID OF SHIGELLA WAS ALSO ATTAINED ON TWO ADDITIONAL TESTS USING RAPID NEGATIVE PANELS. ALSO, THE SAMPLE WAS TESTED ON AN ANALYTICAL PROFILE INDEX (API) STRIP AS A REFERENCE TEST METHOD AND A LOW PROBABILITY ID OF SHIGELLA SP. WAS ATTAINED. PLEASE REFER TO MEDWATCH REPORT NUMBER 2919016-2015-00020 FOR REPORT OF A SIMILAR EVENT WHICH OCCURRED ON (B)(6) 2015. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).