NEG URINE COMBO 33

Additional Manufacturer Narrative

\THE MANUFACTURER PARTICIPATED IN THE SAME PROFICIENCY SURVEY USING (B)(4) 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 UG/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 2919016-2015-00014, 2919016-2015-00015, 2919016-2015-00016, AND 2919016-2015-00018 FOR REPORTS OF A SIMILAR EVENT WHICH OCCURRED ON (B)(6) 2015 RESPECTIVELY. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT (B)(6), (B)(4) SURVEY ISOLATE WAS IDENTIFIED AS LEMINORELLA SPECIES WHEN TESTED ON (B)(6) 2015 USING NEG URINE COMBO 33 (NUC33) PANELS LOT 2015-10-22. REPEAT TESTS WERE PERFORMED ON SEPARATE DATES AND THE SAME ISOLATE WAS IDENTIFIED AS LEMINORELLA SPECIES. EACH PANEL TEST YIELDED BIOTYPE (B)(4), LEMINORELLA SP. 93.14% PROBABILITY. THE CORRECT ID OF THE ISOLATE WAS SHIGELLA BOYDII PER (B)(4) BACTERIOLOGY PARTICIPANT SUMMARY REPORT. THERE WAS NO PATIENT INVOLVED AS THIS WAS A PROFICIENCY SURVEY.