IMMUNOCARD STAT! EHEC

Additional Manufacturer Narrative

REVIEW OF FINAL RELEASE QUALITY CONTROL TESTING INDICATES TEST PERFORMING ACCORDING TO ESTABLISHED SPECIFICATIONS. EVALUATION OF RETAIN KIT LOT FROM SAME LOT TESTED BY MANUFACTURER ON (B)(6) 2017 USING POSITIVE CONTROL, NEGATIVE CONTROL, AND QUALIFIED TOXIN 2 (+) / TOXIN 1 (-) BROTH SAMPLES. CONTROL RESULTS WERE VALID. QUALIFIED SPECIMENS RETURNED EXPECTED RESULTS. REVIEW OF COMPLAINT RECORDS SHOWS NO OTHER COMPLAINTS REPORTED FOR KIT LOT. (B)(4).

Description of Event or Problem

MANUFACTURER BECAME AWARE OF DEATH OF (B)(6) YEAR OLD, FEMALE DUE TO COMPLICATIONS ARISING FROM E. COLI INFECTION, HEMOLYTIC UREMIC SYNDROME (HUS). PATIENT HAD BEEN TESTED USING IMMUNOCARD STAT! EHEC PRODUCT, NEGATIVE RESULTS REPORTED. NOTIFICATION OF PATIENT DEATH WAS RECEIVED ON (B)(6), BY MANUFACTURER PERSONNEL DURING ROUTINE SALES CALL WITH TESTING FACILITY. THE FOLLOWING INFORMATION WAS COLLECTED BY (B)(6). COMPLAINT HANDLING DEPARTMENT (TECHNICAL SERVICE): INSIDE SALES REPRESENTATIVE NOTIFIED TECHNICAL SERVICE THAT CUSTOMER DISCLOSED PATIENT TESTED FOR EHEC AT THEIR FACILITY HAD EXPIRED. PATIENT TEST RESULT WAS REPORTED AS 'NEGATIVE' BY (B)(6) IMMUNOCARD STAT! EHEC, CATALOG 751630. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND WAS TESTED FOR EHEC. PATIENT RESULTS REPORTED AS 'TOXIN 2 POSITIVE' AT OTHER FACILITY. SOMETIME BETWEEN THE INITIAL TESTING AND THE SUBSEQUENT TESTING, PATIENT WAS TREATED WITH ANTIBIOTICS. PATIENT DIED. TECHNICAL SERVICE PERSONNEL CONTACTED CUSTOMER AS FOLLOW-UP. TECHNICAL SERVICE WAS ADVISED BY THE CUSTOMER THAT THEY WERE NOT ABLE TO GIVE ANY ADDITIONAL DETAILS REGARDING THE SITUATION. TECHNICAL SERVICE PERSONNEL REVIEWED TESTING AND PROCEDURE WITH CUSTOMER. CUSTOMER REPORTED USING GN BROTH FOR TESTING. CUSTOMER ACCEPTS PRESERVED AND UNPRESERVED SPECIMENS. CUSTOMER HAS SEEN NO ISSUES WITH TESTING OR QC. THE PERSON PERFORMING THE TEST IS AN EXPERIENCED USER. SPECIMEN IS NO LONGER AVAILABLE FOR ADDITIONAL TESTING. TECHNICAL SERVICE PERSONNEL REQUESTED CONTACT INFORMATION FOR INFECTIOUS DISEASE DOCTOR WHO FIRST NOTIFIED CUSTOMER AND ATTEMPTED TO MAKE CONTACT. FORM 3500 WAS SENT. THE FOLLOWING INFORMATION WAS OBTAINED ON (B)(6) 2017 FROM INFECTIOUS DISEASE DOCTOR: PATIENT AND SIBLING WERE TAKEN TO CUSTOMER FACILITY WHERE THEY WERE ADMITTED AND TESTED FOR STOOL PATHOGENS. BOTH CHILDREN WERE TESTED FOR EHEC AND CAMPYLOBACTER; RESULTS FOR BOTH TESTS WERE REPORTED AS 'NEGATIVE'. CUSTOMER FACILITY USES IMMUNOCARD STAT! EHEC AND CULTURE FOR CAMPYLOBACTER. BOTH CHILDRED WERE DIAGNOSED WITH HEMOLYTIC UREMIC SYNDROME (HUS) FROM A COMBINATION OF DIFFERENT LABORATORIES AND WERE TRANSFERRED TO ALTERNATE FACILITY. ALTERNATE FACILITY REPORTED TO USE VERIGENE ENTERIC PATHOGENS (EP) FOR TESTING. SIBLING WAS TREATED AND RELEASED.