BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO PANEL TYPE 33

    MDR report key: 5258304 · Received December 1, 2015

    Report

    Report Number
    2919016-2015-00112
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 2, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JWY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2050012-12/02/2015-009C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA PROVIDED BY THE CUSTOMER WAS REVIEWED AND CONFIRMED THE HIGH PROBABILITY MISIDENTIFICATION OF S. AUREUS AS S. INTERMEDIUS. THERE WAS NO INDICATION OF INSTRUMENT ISSUES AND RAW DATA AND PROCESSED VALUES FOR CONTROL AND GROWTH WELLS WERE SATISFACTORY. PYR VALUES WERE CONFIRMED AS POSITIVE ON THE PROCESSED PANEL REPORTS. POS COMBO 33 PANEL, LOT 2016-05-04 IS SUBJECT TO A BECKMAN COULTER FIELD ACTION DUE TO FALSELY NEGATIVE RESULTS FOR VOGES-PROSKAUER WITH QUALITY CONTROL AMERICAN TYPE CULTURE COLLECTION ORGANISM STAPHYLOCOCCUS AUREUS ATCC 29213. (B)(4).

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER ISSUED A FIELD ACTION FA-26321 AND AN URGENT MEDICAL DEVICE RECALL LETTER WAS SENT VIA (B)(4) TO THE AFFECTED CUSTOMERS ON 12/04/2015. THE URGENT MEDICAL DEVICE RECALL LETTER INFORMS CUSTOMERS THAT FALSELY NEGATIVE RESULT WAS TRACED TO A SINGLE VOGES-PROSKAUER (VP) COMPONENT LOT USED IN THE MANUFACTURING OF THE MICROSCAN POS COMBO PANEL TYPE 33 LOT 2016-05-04. THE CUSTOMERS WERE ADVISED TO DISCONTINUE USE AND DISCARD ANY REMAINING INVENTORY OF THE AFFECTED LOT. THE VP COMPONENT WHICH RESULTED IN OUT OF SPECIFICATION RESULTS WITH QUALITY CONTROL STAPHYLOCOCCUS AUREUS ATCC 29213 IS NO LONGER IN USE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POS COMBO 33 PANEL, LOT 2016-05-04 RESULTED TO HIGH PROBABILITY MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS S. INTERMEDIUS. THE PYRROLIDONYL-B-NAPHTHYLAMIDE (PYR) RESULTED IN POSITIVE, HOWEVER THE PYR PANEL WELL REACTION SHOULD HAVE BEEN NEGATIVE, ACCORDING TO THE CUSTOMER'S ALTERNATE METHOD . VISUAL VERIFICATION OF THE PYR PANEL WELL CONFIRMED THE POSITIVE RESULT. THE ISOLATE WAS NOT SENT TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING, RATHER THE REPORTED ISOLATE MISIDENTIFICATION WAS BASED ON THE CUSTOMER'S ALTERNATE METHOD I.E. LATEX AGGLUTINATION TEST. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787418 POS COMBO PANEL TYPE 33 MICRO DILUTION PANEL JWY BECKMAN COULTER N/A 2016-05-04

    Patients

    Seq Age Sex Outcome Treatment
    1