POS COMBO 29 PANEL TYPE

Additional Manufacturer Narrative

THE FAILURE MODE FOR THE MISIDENTIFICATION COULD NOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION AVAILABLE. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE POS COMBO 29 (PC29) PANEL (LOT NUMBER NOT PROVIDED) HAS MALFUNCTIONED. CUSTOMER PANEL DATA WAS REVIEWED WITH NO INSTRUMENT OR PANEL ISSUE INDICATED. THE CUSTOMER DID NOT PERFORM REPEAT TESTING OF THE ISOLATE ON THE PC29 PANEL AND THE ISOLATE WAS NO LONGER AVAILABLE FOR ADDITIONAL TROUBLESHOOTING. DATA REVIEW INDICATED SET-UP ISSUE (I.E OVER-INOCULATION) MAY HAVE CONTRIBUTED TO THE REPORTED DISCREPANCY. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED A MISIDENTIFICATION OF (B)(6) AS (B)(6), ON POS COMBO 29 PANEL TYPE, LOT UNKNOWN. THE CUSTOMER PERFORMED OFFLINE TEST METHODS WHICH INDICATED THE ISOLATE WAS (B)(6). STAPHAUREX TEST WAS POSITIVE, PBP2 TEST WAS NEGATIVE, VERIGENE TEST INDICATED (B)(6) POSITIVE, AND REFERENCE LABORATORY REPORTED AS (B)(6) (OX>2). DURING A FOLLOW UP CALL ON (B)(6) 2017, CUSTOMER STATED THE ISOLATE WAS ORIGINALLY REPORTED AS (B)(6), BUT AN AMENDED REPORT WAS SENT TO THE PHYSICIAN WITH THE CORRECT IDENTIFICATION (ID) OF (B)(6). PER THE PHYSICIAN, PATIENT TREATMENT WAS AFFECTED WITH THE CHANGE IN ID HOWEVER THE CUSTOMER COULD NOT PROVIDE ADDITIONAL DETAILS. CUSTOMER STATED THE PATIENT HAD BEEN DISCHARGED BUT IT WAS UNKNOWN IF PATIENT WAS DISCHARGED PRIOR TO THE AMENDED REPORT. RETEST OF THE ISOLATE IS NOT POSSIBLE AS IT WAS NO LONGER AVAILABLE. THERE WAS NO REPORT OF DEATH OR INJURY IN CONNECTION WITH THIS EVENT.