BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CALIBRITE 3 BEADS

    MDR report key: 11259331 · Received February 1, 2021

    Report

    Report Number
    2916837-2021-00040
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 12, 2021
    Report Date
    February 16, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903404865
    PMA / PMN Number
    K973483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2916837-2021-00040 WAS SENT IN ERROR. THERE WERE NO PATIENT SAMPLES INVOLVED, AND REAGENT LOT-TO-LOT VARIATION IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD CALIBRITE¿ 3 BEADS THERE WAS A POOR FL3 PERFORMANCE. CONFIRMATORY TESTING PERFORMED RUNNING TEST SIMULTANEOUSLY ON TO RULE OUT MACHINE ISSUE. NEW LOT OF BEADS PASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NATURE OF INCIDENT: POOR FL3 PERFORMANCE. THE AFFECTED CALIBRITE BEAD LOT NUMBER IS 0002577. TESTED SAME CALIBRITE BEAD ON 2 UNIT FACSCALIBUR SIMULTANEOUSLY (MACHINE A & MACHINE B) TO RULE OUT MACHINE PROBLEM. RUN FACSCOMP USING DIFFERENT LOT OF CALIBRITE BEAD #0212458 AND IT SHOW PASS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD CALIBRITE¿ 3 BEADS THERE WAS A POOR FL3 PERFORMANCE. CONFIRMATORY TESTING PERFORMED RUNNING TEST SIMULTANEOUSLY ON TO RULE OUT MACHINE ISSUE. NEW LOT OF BEADS PASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NATURE OF INCIDENT: POOR FL3 PERFORMANCE. THE AFFECTED CALIBRITE BEAD LOT NUMBER IS 0002577 TESTED SAME CALIBRITE BEAD ON 2 UNIT FACSCALIBUR SIMULTANEOUSLY (MACHINE A & MACHINE B) TO RULE OUT MACHINE PROBLEM. RUN FACSCOMP USING DIFFERENT LOT OF CALIBRITE BEAD #0212458 AND IT SHOW PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154604 BD CALIBRITE 3 BEADS COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 340486 0002577 00382903404865

    Patients

    Seq Age Sex Outcome Treatment
    1