BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 2143204 · Received June 28, 2011

    Report

    Report Number
    2919069-2011-00508
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. PATIENT PROBLEM CODE: NO KNOWN IMPACT OR CONSEQUENCE TO PT. (B)(4). INCORRECT MEASUREMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) ARRIVED AT THE CUSTOMER SITE AND REPLACED A WORN OUT RBC/PLT TRANSDUCER. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 07H80-01, REVISION E, CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THE CURRENT INVESTIGATION AND EVENT DETAILS, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELLDYN 1800 INSTRUMENT. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Additional Manufacturer Narrative · 1

    FOR THE INITIAL MDR SUBMITTED ON (B)(4) 2011, MFR RECEIVED DATE SHOULD HAVE BEEN (B)(4) 2011. FOR THE FOLLOW-UP MDR SUBMITTED ON (B)(4) 2011, MFR RECEIVED DATE SHOULD HAVE BEEN (B)(4) 2011. FOR THE FOLLOW-UP MDR SUBMITTED ON (B)(4) 2011, MANUFACTURE DATE SHOULD HAVE BEEN 01/2007.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 1800 ANALYZER IS GENERATING ERRATIC PLATELET RESULTS WITH NORMAL BACKGROUND RESULTS INTERMITTENTLY HIGH OUT OF SPECIFICATIONS THROUGHOUT THE DAY. THE BACKGROUND COUNT IS REPEATED AND FALLS WITHIN SPECIFICATIONS. THE CUSTOMER GAVE ONE EXAMPLE OF PATIENT PLATELET RESULTS OF 492, 348 AND 992 K/UL (LAB'S NORMAL RANGE IS 142 - 424 K/UL) AND A PLATELET BACKGROUND COUNT OF 336 (SPECIFICATION IS LESS THAN 10 COUNTS). THE ELECTRICAL BACKGROUND COUNT IS WITHIN SPECIFICATIONS. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. A SERVICE CALL WAS INITIATED.

    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 METERING TUBE ASSY LN: 8921027701| TRANSDUCER ASSY, RBC LN:8921002101| TRANSDUCER ASSY, RBC LN:8921002101| METERING TUBE ASSY LN: 8921027701