BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9445102 · Received December 10, 2019

    Report

    Report Number
    1024879-2019-02099
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 22, 2019
    Report Date
    February 3, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOT. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD TECHNICAL SERVICES PROVIDED TROUBLESHOOTING WITH THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9242155 IT WAS REPORTED THAT THE PROLACTIN RESULTS WERE HIGH. 1 OF 3: PATIENT 1. PROLACTIN RESULTS WERE HIGH. PATIENTS HAVE NOT BEEN RE-DRAWN. RECEIVED AN EMAIL FROM THE CUSTOMER: GOOD MORNING. I DISCUSSED THE PROLACTIN RESULTS AND THE ISSUE WE HAD LAST MONTH WITH THE HIGH PROLACTIN THAT DID NOT REPEAT WITH THE DRS AND THEY SAID THEY WERE NOT SURPRISED THAT THE PROLACTIN RESULTS WERE HIGH AND THEY DID NOT NEED TO REPEAT THE TEST RESULTS. SO, I STILL DO NOT KNOW WHAT HAPPENED LAST MONTH, BUT OBVIOUSLY I'M A LITTLE GUN SHY NOW AND JUMPED THE GUN. I AM SORRY FOR ANY INCONVENIENCE I HAVE CAUSED AND THANK YOU FOR YOUR HELP. SPOKE WITH THE CUSTOMER. THE SAMPLES WERE RE-RUN ON ANOTHER ANALYZER AND THE SAME HIGH RESULTS WERE OBTAINED. SHE WILL GET BACK TO ME WITH THE ANALYZER OF THE RE-RUN SAMPLES. SHE STATED THAT SHE NEEDS TO PERSUADE THE PATIENTS TO COME BACK AND BE RE-DRAWN. SPOKE WITH THE CUSTOMER. THE PATIENTS WERE NOT EXPECTED TO HAVE HIGH RESULTS. THE PROLACTIN LEVELS OF THE FIRST 2 PATIENTS WERE 114 AND 147. THE NORMAL VALUES ARE 2.74-26.72. THE SAMPLES ARE BEING RE-RUN BY ANOTHER ANALYZER AT ANOTHER FACILITY. SHE WILL CONTACT ME WITH THE RESULTS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9242155. IT WAS REPORTED THAT THE PROLACTIN RESULTS WERE HIGH. 1 OF 3: PATIENT 1. PROLACTIN RESULTS WERE HIGH. PATIENTS HAVE NOT BEEN RE-DRAWN RECEIVED AN EMAIL FROM THE CUSTOMER: GOOD MORNING. I DISCUSSED THE PROLACTIN RESULTS AND THE ISSUE WE HAD LAST MONTH WITH THE HIGH PROLACTIN THAT DID NOT REPEAT WITH THE DRS AND THEY SAID THEY WERE NOT SURPRISED THAT THE PROLACTIN RESULTS WERE HIGH AND THEY DID NOT NEED TO REPEAT THE TEST RESULTS. SO, I STILL DO NOT KNOW WHAT HAPPENED LAST MONTH, BUT OBVIOUSLY I'M A LITTLE GUN SHY NOW AND JUMPED THE GUN. I AM SORRY FOR ANY INCONVENIENCE I HAVE CAUSED AND THANK YOU FOR YOUR HELP. SPOKE WITH THE CUSTOMER. THE SAMPLES WERE RE-RUN ON ANOTHER ANALYZER AND THE SAME HIGH RESULTS WERE OBTAINED. SHE WILL GET BACK TO ME WITH THE ANALYZER OF THE RE-RUN SAMPLES. SHE STATED THAT SHE NEEDS TO PERSUADE THE PATIENTS TO COME BACK AND BE RE-DRAWN. SPOKE WITH THE CUSTOMER. THE PATIENTS WERE NOT EXPECTED TO HAVE HIGH RESULTS. THE PROLACTIN LEVELS OF THE FIRST 2 PATIENTS WERE 114 AND 147. THE NORMAL VALUES ARE 2.74-26.72. THE SAMPLES ARE BEING RE-RUN BY ANOTHER ANALYZER AT ANOTHER FACILITY. SHE WILL CONTACT ME WITH THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243322 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 9242155 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other