BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-CAL® CALIBRATOR

    MDR report key: 2253712 · Received September 19, 2011

    Report

    Report Number
    1061932-2011-01467
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KRY
    PMA / PMN Number
    K962988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. SENT REPLACEMENT PRODUCT TO THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 THEY OBSERVED A LEAK AROUND THE TOP OF A S-CAL CALIBRATOR VIAL. AT THE TIME THE LEAK WAS IDENTIFIED THE INSTRUMENT CALIBRATION HAD YIELDED TWO OUTLIERS AND THE CUSTOMER HAD BLEACHED THE SYSTEM IN RESPONSE TO THE CALIBRATION IMPRECISION. NO PATIENT RESULTS WERE INVOLVED IN THIS EVENT. THE HEALTHCARE WORKER INVOLVED IN THIS EVENT WAS WEARING PERSONAL PROTECTIVE EQUIPMENT, WHICH INCLUDED GLOVES, AT THE TIME OF OCCURRENCE. NO PERSONNEL SOUGHT MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. THERE WAS NO BIOHAZARDOUS EXPOSURE TO PERSONNEL UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS NO EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-CAL® CALIBRATOR CALIBRATOR FOR PLATELET COUNTING KRY BECKMAN COULTER INC. NA 1169145F

    Patients

    Seq Age Sex Outcome Treatment
    1