BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 2241926 · Received September 9, 2011

    Report

    Report Number
    2919069-2011-00668
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT TEXT, LABELING CLAIMS, AND COMPLAINT RECORDS WERE REVIEWED. OUR COMPLAINT RECORDS DID NOT SHOW A PRODUCT ISSUE SIMILAR TO THIS INCIDENT. THE RETURNED KEYBOARD WAS TESTED WITH OUR CELL-DYN 1800 INSTRUMENTS; DATA ENTRY SIMILAR TO WHAT WAS DESCRIBED IN THE CUSTOMER'S COMPLAINT WAS PERFORMED, AND EXPECTED RESULTS WERE OBSERVED. WE WERE UNABLE TO IDENTIFY A PRODUCT ISSUE, AND IT IS INCONCLUSIVE AS TO WHY THE CUSTOMER OBSERVED INCORRECT GENERATION OF SAMPLE IDENTIFICATION NUMBERS AND TEXT. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE KEYBOARD USED WITH THE CELLDYN 1800.

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE OPERATES DIFFERENTLY THAN EXPECTED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHEN ENTERING PATIENT ID NUMBERS USING THE CELL-DYN 1800 KEYBOARD, THEY NOTED THAT NUMBERS 6, 7, 8, 9, AND 0 WERE NOT BEING ENTERED CORRECTLY ON THE SCREEN. FOR EXAMPLE, WHEN KEYING IN 6, 7, AND 8, THE SCREEN SHOWED "6578" INSTEAD. WHEN KEYING IN 9, 0, THE SCREEN SHOWED "09." THE ABBOTT CUSTOMER TECHNICAL ADVOCATE HAD THE CUSTOMER TURN OFF THE CELL-DYN 1800, RE-SEAT THE KEYBOARD CABLE, WAIT FOR 1 MIN, RE-CONNECT KEYBOARD CABLE AND TURN THE CELL-DYN BACK ON. THE SPECIFIED NUMBERS STILL DID NOT POPULATE CORRECTLY ON THE SCREEN. IN ADDITION, THE CUSTOMER NOTED THE LETTER KEYS WERE NOT BEING DISPLAYED CORRECTLY. THE FOLLOWING PATTERN WAS NOTED: KEY IN T, Y, U AND THE SCREEN SHOWS "YTRU"; KEY IN I, O, P AND THE SCREEN SHOWS "PIO"; KEY IN G, H, J AND THE SCREEN SHOWS "HGFJ"; KEY IN K, L, B AND THE SCREEN SHOWS "JLK"; KEY IN N, M AND THE SCREEN SHOWS "NBVM". THE CUSTOMER NOTED THE INCORRECT ID NUMBERS ON THE SCREEN AND DID NOT CONTINUE TO RUN SAMPLES. THERE WAS NO REPORT OF RESULTS ASSIGNED TO THE INCORRECT PATIENT ID NUMBER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 KEYBOARD WITH ADAPTER CABLE KIT,| CD1800 LIST # 7H78-01| CD1800 LIST # 7H78-01| KEYBOARD WITH ADAPTER CABLE KIT,