NEG BREAKPOINT COMBO 34

Additional Manufacturer Narrative

THE MANUFACTURER PARTICIPATED IN THE SAME PROFICIENCY SURVEY USING (B)(6) SURVEY 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 2919016-2015-00011 AND 2919016-2015-00012 FOR REPORTS OF A SIMILAR EVENT WHICH OCCURRED ON 02/09/2015 AND 02/20/2015 RESPECTIVELY. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS CF (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT (B)(6) SURVEY ISOLATE WAS IDENTIFIED AS LEMINORELLA SPECIES. THE SPECIMEN SOURCE WAS STOOL AND THE ISOLATE WAS GROWN ON BLOOD AGAR PLATE (BAP) AND MACCONKEY (MAC) AGAR PLATE. THE ISOLATE WAS TESTED THREE TIMES ON SEPARATE DATES USING AN OVERNIGHT CONVENTIONAL GRAM NEGATIVE NBC34 PANEL. EACH PANEL TEST YIELDED BIOTYPE 41000002, LEMINORELLA SP. 93.14% PROBABILITY. THE CORRECT ID OF THE ISOLATE WAS SHIGELLA BOYDII PER 2015 CAP D-A BACTERIOLOGY PARTICIPANT SUMMARY REPORT. THERE WAS NO PATIENT INVOLVED AS THIS WAS A PROFICIENCY SURVEY.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE TYPOGRAPHICAL ERROR ON THE LAST PARAGRAPH ENTERED IN THE INITIAL MDR REPORT AS FOLLOWS: PLEASE REFER TO MEDWATCH REPORT NUMBER 2919016-2015-00011 AND 2919016-2015-00012 FOR REPORTS OF A SIMILAR EVENT WHICH OCCURRED ON (B)(6) 2015 AND (B)(6) 2015 RESPECTIVELY. (NOTE: DATES ENTERED ON THE INITIAL REPORT WERE (B)(6) 2015 AND (B)(6) 2015 RESPECTIVELY).