BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1060039 · Received June 12, 2008

    Report

    Report Number
    2919069-2008-00605
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    Z-1165-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMERS REPORTED THAT THE HEMOGLOBIN BACKGROUND COUNTS WERE OUT OF THE SPECIFICATION HIGH AFTER INSTALLING AND RUNNING THE CELL-DYN SAPPHIRE HEMOGLOBIN REAGENT SYRINGE LIST NUMBER 08H49-02 ON THE CELL-DYN SAPPHIRE INSTRUMENT. THE SPECIFICATION FOR THE HEMOGLOBIN BACKGROUND IS LESS THAN OR EQUAL TO 0.10 GRAMS PER DECILITERS PER THE CELL-DYN SAPPHIRE OPERATORS MANUAL. BACKGROUND COUNTS MUST BE WITHIN SPECIFICATION PRIOR TO REPORTING OF PATIENT SAMPLES. INVESTIGATION OF THIS ISSUE FOUND THAT THE ELEVATED HGB BACKGROUND COUNT IS DUE TO EXCESS LUBRICANT USED BY THE VENDOR DURING THEIR MANUFACTURING PROCESS OF THE CELL-DYN SAPPHIRE HEMOGLOBIN REAGENT SYRINGE THAT IS PRESENT ON THE TIP OF THE PLUNGER, LUBRICANT SHOULD ONLY BE APPLIED TO THE SIDE OF THE PLUNGER. THE CELL-DYN SAPPHIRE HEMOGLOBIN REAGENT SYRINGE LIST NUMBER 08H49-02 IS DISTRIBUTED FOR USE ON THE CELL-DYN SAPPHIRE INSTRUMENT ONLY. THIS ISSUE HAS NO IMPACT ON OTHER PLATFORMS OR INSTRUMENTS. THE FOLLOWING CORRECTIVE ACTIONS WERE PUT IN PLACE IN ORDER TO ADDRESS THE ISSUE A PRODUCT RECALL LETTER FA11JAN2008 WAS ISSUED WITH ITS ASSOCIATED FIELD ACTION AND DISTRIBUTED TO AFFECTED CUSTOMERS. AFFECTED CELL-DYN SAPPHIRE HEMOGLOBIN REAGENT SYRINGES WERE IDENTIFIED TO HAVE PACKAGED DATES OF (B)(6) 2007 THROUGH (B)(6) 2007 FOR FA11JAN2008. THE VENDOR (B)(4) HAS IMPLEMENTED AND UPDATED THEIR PROCEDURES IN REGARDS TO THE APPLICATION OF THE LUBRICANT AND CLEANING OF THE CELL-DYN SAPPHIRE HEMOGLOBIN REAGENT SYRINGE AS PART OF THEIR MANUFACTURING PROCESS TO ADDRESS THE EXCESS LUBRICANT ISSUE. ABBOTT (B)(4) HAS IMPLEMENTED AN INCOMING QUALITY INSPECTION REQUIREMENT FOR THE CELL-DYN SAPPHIRE HEMOGLOBIN REAGENT SYRINGE PRIOR TO TESTING OR USE ON THE MANUFACTURING LINE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER IS QUESTIONING THE HIGH HEMOGLOBIN BACK GROUNDS GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER, AFTER INSTALLING THE NEW CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE LIST # 8H49-02. PRIMING THE ANALYZER AND PERFORMING AN AUTO-CLEAN, DID NOT RESOLVE THE ISSUE. THERE WAS NO IMPACT TO PT MGMT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIST# 8H49-02| CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LLN 8H49-02| CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE