BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT/ALERT BPA

    MDR report key: 3251970 · Received July 25, 2013

    Report

    Report Number
    3002769706-2013-00004
    Event Type
    Death
    Date Received
    July 25, 2013
    Date of Event
    January 16, 2013
    Report Date
    July 25, 2013
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    PMA / PMN Number
    BK050037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH RECORD AND QC TESTING RESULTS FOR BACT/ALERT BPA CULTURE BOTTLE, LOT NUMBER 1032201, BY BIOMERIEUX, DID NOT REVEAL ANY ABNORMALITIES OR INDICATORS OF PRODUCT NON-CONFORMITY. THERE WERE NO DISCREPANCIES IN THE QC RELEASE DATA, AND THE RESULTS WERE WITHIN THE IDENTIFIED SPECIFICATIONS. THE RESULTS OF THE INVESTIGATION DID NOT DETECT A PRODUCT MALFUNCTION OR PRODUCT ISSUE ASSOCIATED WITH THE BACT/ALERT INSTRUMENT OR BACT/ALERT BPA CULTURE BOTTLE, LOT NUMBER 1032201 ASSOCIATED WITH THIS COMPLAINT. THE INSTRUCTIONS IN THE PACKAGE INSERT ARE ADEQUATE AND CORRECTLY INFORM THE CUSTOMER OF PRECAUTIONS TO REDUCE THE POTENTIAL OF AN ADVERSE EVENT. THIS EVENT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THERE IS NO INFORMATION AVAILABLE TO CLEARLY SEPARATE THE BPA RESULT AND THE PATIENT DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2013, BIOMERIEUX BECAME AWARE OF A PATIENT DEATH ASSOCIATED WITH A FALSE NEGATIVE BACT/ALERT BPA RESULT FOR A POOLED PLATELET SAMPLE. THE PATIENT HAD BEEN DIAGNOSED WITH PANCYTOPENIA, NEUTROPENIA AND LEUKEMIA, AND WAS UNDERGOING CHEMOTHERAPY FOR >1 MONTH. THE PATIENT RECEIVED A TRANSFUSION OF FOUR-DAY-OLD POOLED PLATELETS (B)(6) 2013 AT 22:00, AND WENT INTO SEPTIC SHOCK. TESTING OF THE PATIENT'S BLOOD DETECTED STREPTOCOCCI GROUP A. THE PATIENT DIED (B)(6) 2013 AT 12:50. INTERNAL INVESTIGATION AT (B)(6) ISOLATED THE CAUSE TO AN ASYMPTOMATIC BLOOD DONOR WHO HAD A RESPIRATORY INFECTION 1-2 WEEKS PRIOR TO BLOOD DONATION. THE DONOR HAD STREPTOCOCCI GROUP A. FURTHER TESTING OF ALL PRODUCTS PRODUCED WHICH CONTAIN THIS DONORS BLOOD WERE POSITIVE FOR STREPTOCOCCI GROUP A. THE CUSTOMER'S SAMPLE PROCESSING PROCEDURE INDICATES TO WAIT 24 HOURS BEFORE REMOVING THE SAMPLE FROM THE POOLED PLATELETS; HOWEVER, IN THIS CASE, THE SAMPLE OF 8-10ML FROM A FIVE-DONOR PLATELET POOL WAS REMOVED AT 18 HOURS. THE ASSOCIATED BACT/ALERT BPA BOTTLE CONTAINING THE POOLED PLATELETS REMAINED "NEGATIVE" FOR THE MAXIMUM MONITORING PERIOD OF 7 DAYS. AS INDICATED IN THE PACKAGE INSERT, A REPORT OF "NEGATIVE" SHOULD NOT BE INTERPRETED AS MEANING THAT THE ORIGINAL PRODUCT IS STERILE. THE NEGATIVE STATUS COULD BE DUE TO UNDER-INOCULATION OF THE BOTTLE, NO ORGANISMS PRESENT IN THE INOCULUM, THE NUMBER OF ORGANISMS WERE TOO SMALL FOR DETECTION, OR A CULTURE BOTTLE/MEDIUM THAT DOES NOT SUPPORT THE GROWTH OF THE ORGANISM. FOR BEST OVERALL RECOVERY WHEN CULTURING PLATELET SPECIMENS IT IS STRONGLY RECOMMENDED THAT MORE THAN ONE TYPE OF CULTURE BOTTLE BE UTILIZED (E.G., ONE AEROBIC AND ONE ANAEROBIC). THE PACKAGE INSERT ALSO STATES THAT MORE THAN ONE TYPE OF CULTURE BOTTLE SHOULD BE USED WHEN CULTURING PLATELET SPECIMENS (E.G. ONE AEROBIC, ONE ANAEROBIC CULTURE BOTTLE) FOR BEST OVERALL RECOVERY. IN THIS CASE, THE CUSTOMER ONLY USED AN AEROBIC (BPA) BOTTLE WHEN CULTURING THE PLATELET SPECIMENS. AS PART OF THE BIOMERIEUX INTERNAL INVESTIGATION, THE SUBMITTED BACT/ALERT INSTRUMENT DATABASE WAS REVIEWED AND THERE WERE NO INDICATIONS OF INSTRUMENT ERRORS OR OPERATOR ERRORS THAT COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349337 BACT/ALERT BPA BACT/ALERT BPA MDB BIOMERIEUX, INC. 1032201

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death