BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D

Additional Manufacturer Narrative

H6. INVESTIGATION SUMMARY: NO RETURNS WERE RECEIVED FOR THIS COMPLAINT. TO INVESTIGATE THE COMPLAINT ON CATALOG 227901, LOT 3159723, A RETAINED SAMPLE OF THE COMPLAINT LOT WAS TESTED, ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, WITH AVAILABLE CULTURES REPRESENTING HAEMOPHILUS INFLUENZAE TYPE D. FOR EACH ANTISERUM TEST, A PORTION OF CULTURE WAS REMOVED FROM THE AGAR PLATE AND MIXED INTO ONE DROP OF ANTISERUM ON A SLIDE. IN ADDITION, EACH CULTURE WAS TESTED IN A DROP OF SALINE TO CHECK FOR ROUGHNESS. EACH SLIDE WAS ROTATED FOR 1 MINUTE BEFORE READING THE REACTION. RESULTS WERE AS FOLLOWS: 4+ REACTIONS WERE OBSERVED WITH THE RETAIN TESTED, WITH THE TYPE D CULTURES TESTED. NO REACTIVITY WAS OBSERVED WHEN THE CULTURES WERE TESTED IN SALINE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE TESTING PERFORMED. THE BATCH HISTORY RECORD FOR THE LOT WAS REVIEWED AND FOUND SATISFACTORY. COMPLAINTS FOR THE PRODUCT LINE WERE REVIEWED. THERE HAVE BEEN NO OTHER COMPLAINTS IN THE THREE-YEAR PERIOD REVIEWED; BD WILL CONTINUE TO MONITOR FOR TRENDS. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME. H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 3.

Additional Manufacturer Narrative

H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 3.