BD BBL COAGULASE PLASMA, RABBIT WITH EDTA
Received Jul 29, 2021 · Event occurred Jun 15, 2021
Report 1025402-2021-00006 · MDR key 12248718
Device
Generic name
Plasma, Coagulase, Human, Horse And Rabbit
Manufacturer
Lee Laboratories, Inc.Model number
240827Catalog number
240827
Lot number
0275787
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
INVESTIGATION SUMMARY: RETURNS WERE EXPECTED BUT NONE WERE RECEIVED FOR THIS COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE TEST PROCEDURE AND EQUIPMENT BEING USED BY THE CUSTOMER, BUT NONE WAS PROVIDED. TO INVESTIGATE THE COMPLAINT ON CATALOG NUMBER 240827 BATCH 0275787, A RETAINED SAMPLE OF THE COMPLAINT LOT WAS TESTED, ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, WITH AVAILABLE CULTURE STRAINS OF STAPHYLOCOCCUS AUREUS. BASED ON THE COMPLAINT NOTES, THE CUSTOMER IS USING PLATE-GROWN CULTURES FOR TESTING. THEREFORE, TESTING OF THE LOT WAS PERFORMED USING COLONIES OF EACH STRAIN OF STAPHYLOCOCCUS AUREUS PICKED DIRECTLY FROM AGAR PLATES. TO TEST THE LOT, TEST TUBES CONTAINING 0.5 ML OF THE COAGULASE PLASMA WERE PREPARED, AND 3 OR MORE COLONIES, UP TO A 1 ¿L LOOP FULL, WERE PICKED AND ADDED TO EACH TUBE. ALL TUBES WERE INCUBATED AT 37°C AND READ EVERY TWO HOURS, UP TO 6 HOURS. RESULTS WERE AS FOLLOWS: 2+ TO 4+ CLOTS WERE OBSERVED AT 2 HOURS AND 4+ CLOTS WERE OBSERVED AT 4 AND 6 HOURS WITH ALL STRAINS TESTED; THE TEST WAS DISCONTINUED AFTER 6 HOURS INCUBATION. THE COMPLAINT WAS NOT CONFIRMED BASED ON THIS TESTING. THE BATCH HISTORY RECORD FOR THE LOT WAS REVIEWED AND FOUND SATISFACTORY. NO QUALITY NOTIFICATIONS WERE ISSUED FOR THE PRODUCT BATCH. COMPLAINTS FOR THE PRODUCT WERE REVIEWED. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS PRODUCT IN THE THREE-YEAR PERIOD REVIEWED; BD QUALITY WILL CONTINUE TO MONITOR CLOSELY FOR TRENDS ASSOCIATED WITH FALSE NEGATIVE RESULTS. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING 49 BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT PATIENT STAPH AUREUS ISOLATES ARE NOT CLOTTING WITH USE OF 240827 LOT 0275787. "