BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1881962 · Received October 12, 2010

    Report

    Report Number
    1181121-2010-00002
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Report Date
    October 11, 2010
    Product Code
    GJS
    PMA / PMN Number
    K940082
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE THAT FAILED IN THE FIELD LEADING TO THE EKOMED CUSTOMER COMPLAINT WAS NOT RETURNED. MATERIAL FROM THE SAME LOT WAS REQUESTED FROM FISHER SCIENTIFIC AND DID REPLICATE THE PROLONGED CLOT TIMES. BECAUSE MDR 1181121-2010-00001 WAS OPEN FOR INVESTIGATION, AND EXTENSIVE TESTING HAD BEEN CONDUCTED THE COMPLAINT REGARDING A NEW VIAL SIZE, WITH AN ALTERNATIVE SUPPLIER NARROWED THE SCOPE OF THE INVESTIGATION. IT WAS NOTED THAT THE MAJORITY OF THE VIALS IMPACTED EXHIBIT "INAPPROPRIATE VACUUM" IN THE VIAL, LEADING TO PROLONGED CLOT TIMES. AS A CORRECTIVE ACTION, ALL MATERIALS IN HOUSE HAVE BEEN QUARANTINED. AN IN LINE PROCESS HAS BEEN ESTABLISHED USING A GAS IONIZATION DETECTION SYSTEM TO DETECT VIALS THAT HAVE A LACK OF VACUUM. DATA GATHERED OF IN HOUSE TESTED MATERIALS SHOWED A FAILURE RATE OF LESS THAN 1%. ALL MATERIALS ARE BEING 100% TESTED TO ENSURE DETECTION PRIOR TO RELEASE, THIS INCLUDES FINISHED INVENTORY AS WELL.

    Description of Event or Problem · 1

    NO INCIDENTS OF ACTUAL ADVERSE EVENTS HAVE BEEN REPORTED AT THIS TIME. ON (B)(6) 2010, EKOMED REPORTED RECEIVING A CUSTOMER COMPLAINT, STATING PROLONGED CLOT TIMES WHEN RUNNING CONTROLS. OUR INTERNAL INVESTIGATION HAS CONFIRMED THE PROLONGED CLOT TIMES ON THIS LOT. BECAUSE THE STATEMENT "NORMAL AND ABNORMAL CONTROLS SHOULD BE RUN AT THE INITIATION OF TESTING EACH DAY AND AT LEAST ONCE EACH SHIFT, OR WITH EACH GROUP OF ASSAYS. CONTROLS SHOULD ALSO BE TESTED WITH EACH REAGENT CHANGE OR MAJOR INSTRUMENT ADJUSTMENT" IS CONTAINED IN THE PRODUCT INSERT, THE VIALS IMPACTED SHOULD BE DETECTED AS ABNORMAL PRIOR TO UTILIZATION. BASED ON MEDICAL OPINION, RISK IS PRESENTED IF THE INSTRUCTIONS FOR QUALITY CONTROL ARE NOT FOLLOWED IN THE FIELD. FOR THE VAST MAJORITY OF PTS, THERE WOULD BE NO CONSEQUENCE WHATSOEVER. FOR THE RARE PT WHOSE WARFARIN IS UNDER DOSED AND SUFFERS A STROKE, THE CONSEQUENCES CAN BE SEVERE AND IRREVERSIBLE. THE HAZARD ANALYSIS SUMMARY WAS A VERY LOW RISK OF SEVERE ADVERSE HEATH CONSEQUENCE. THIRTEEN KITS WERE DISTRIBUTED IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GJS

    Patients

    Seq Age Sex Outcome Treatment
    1