BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-CAL® CALIBRATOR

    MDR report key: 2250512 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01458
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KRY
    PMA / PMN Number
    K962988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. EVALUATION OF PICTURES OF THE EVENT SHOW THE PRESENCE OF MULTIPLE SMUDGES ON THE OUTER PACKAGE OF THE S-CAL CALIBRATOR PACKAGING. THE SOURCE OF THE SMUDGES IS UNKNOWN. IT IS UNKNOWN AS TO WHAT THE RED SMUDGES ARE. 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 RED SMEARS ON THE OUTSIDE OF THE S-CAL CALIBRATOR PACKAGING THAT WAS THOUGHT TO BE POSSIBLY BLOOD OR RED INK. THE SMEARS WERE DISCOVERED DURING RECEIVING INSPECTION. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. UPON OBSERVANCE OF THE SMEARS THE SUSPECT PRODUCTS WERE KEPT IN A PLASTIC BAG AND QUARANTINED AS NON-CONFORMING GOODS. THE PERSONNEL INVOLVED IN THIS EVENT WERE WEARING PERSONAL PROTECTIVE EQUIPMENT, WHICH INCLUDED LABORATORY COATS, GLOVES AND FACE MASKS, AT THE TIME OF OCCURRENCE. THERE WAS NO BIOHAZARDOUS EXPOSURE TO PERSONNEL UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-CAL® CALIBRATOR CALIBRATOR FOR PLATELET COUNTING KRY BECKMAN COULTER INC. NA 1158175F

    Patients

    Seq Age Sex Outcome Treatment
    1