BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 3622343 · Received February 11, 2014

    Report

    Report Number
    2919069-2014-00005
    Event Type
    Injury
    Date Received
    February 11, 2014
    Report Date
    December 22, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ERROR NEEDING A CORRECTION WAS IDENTIFIED ON (B)(6) 2014. THE RECEIPT DATE SHOULD BE (B)(6) 2013 (THE DATE THE COMPLAINT WAS REGISTERED AND AN ENGINEER LOCATED CRIMPED TUBING). THE SECTION WAS UPDATED ACCORDINGLY. NOTE: THE INFORMATION ABOUT THE IMPACT TO THE PATIENT WAS REPORTED CORRECTLY AS (B)(6) 2014 AND HAS NOT CHANGED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ABOUT THE PATIENT WAS OBTAINED ON 2/14/2014: THE CRITERIA FOR TRANSFUSION ARE WHEN THERE IS A SIGNIFICANT SUDDEN DROP IN HEMOGLOBIN USUALLY DUE TO BLOOD LOSS. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED CELL OBTAINED FROM THE (B)(6). DEVICE EVALUATION COMPLETED 2/19/2014: FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE TYGON TUBING, LIST NUMBER 3130548, WAS RESEATED/RECONNECTED DUE TO BEING WORN OUT AND THE TUBING ORIENTATION WAS CORRECTED TO RESOLVED THE SERVICE ISSUE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED HEMOGLOBIN THAT RESULTED IN AN ADVERSE EVENT FOR ONE PATIENT ON THE CELL-DYN CD3700 ANALYZER. NO SPECIFIC DATA WAS PROVIDED OR AVAILABLE. THE PATIENT WAS GIVEN A TRANSFUSION BECAUSE OF THEIR LOW HEMOGLOBIN RESULT. NO FURTHER PATIENT OR TREATMENT DETAILS WERE AVAILABLE. AN ABBOTT FIELD SERVICE TECHNICIAN INSPECTED THE INSTRUMENT AND FOUND ONE OF THE PIECES OF TUBING BETWEEN THE MIXING CHAMBER AND HGB FLOW CELL WAS CRIMPED AND CAUSED A FLOW CLOG. THE TECHNICIAN CORRECTED THE TUBING ORIENTATION AND VERIFIED THE INSTRUMENT IS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89246 CELL-DYN 3700 SL ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other