BD DIFCO; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4
Received Mar 2, 2021 · Event occurred Feb 3, 2021
Report 1025402-2021-00002 · MDR key 11401353
Device
Generic name
Antisera, All Types, Listeria Monocytogenes
Manufacturer
Lee Laboratories, Inc.Model number
223021Catalog number
223021
Lot number
9200273
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: RETURN SAMPLES DO NOT APPLY; THIS COMPLAINT WAS INITIATED BASED ON INTERNAL TESTING OF THE PRODUCT, PERFORMED BY BD. TO INVESTIGATE THE COMPLAINT, A RETAINED SAMPLE OF THE LOT WAS TESTED, PER THE PRODUCT PACKAGE INSERT, WITH MULTIPLE LOTS OF LISTERIA O ANTIGEN TYPE 1 (SLIDE), ONE OF THE QC ANTIGENS FOR THE PRODUCT, ALSO MANUFACTURED AT BD GRAYSON. THE RETAINED VIAL OF ANTISERUM DEMONSTRATED NEGATIVE REACTIONS AT 2 MINUTES WITH THESE QC ANTIGEN LOTS. TO FURTHER INVESTIGATE THE ISSUE, THE ANTISERUM WAS ALSO TESTED WITH SEVERAL CULTURES REPRESENTING LISTERIA MONOCYTOGENES TYPE 1 (TYPE 1/2A AND TYPE 1/2B CULTURE STRAINS WERE USED IN THIS TESTING). REACTIONS OBSERVED WITH THE CULTURES TESTED RANGED FROM NEGATIVE TO 3+. THE COMPLAINT WAS CONFIRMED BASED ON THESE RESULTS. THE BATCH HISTORY RECORD FOR THE LOT WAS REVIEWED AND FOUND SATISFACTORY; NO QUALITY NOTIFICATIONS WERE ISSUED FOR THIS BATCH. THE COMPLAINT WAS CONFIRMED. CAPA INITIATION DETERMINATION (CID) (B)(4) WAS COMPLETED ON 02/08/2021. BASED ON THE CID, THE TEAM DECISION WAS TO INITIATE A CAPA. H3 OTHER TEXT : SEE H10.
Description of Event or Problem
IT WAS REPORTED DURING BENCH TESTING WITH BD DIFCO¿; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4 A WEAK REACTION WAS OBSERVED WITH 4 VIALS. RESULTS WERE NOT REPORTED THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
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 DURING BENCH TESTING WITH BD DIFCO¿; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4 A WEAK REACTION WAS OBSERVED WITH 4 VIALS. RESULTS WERE NOT REPORTED THERE WAS NO REPORT OF PATIENT IMPACT.