BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE C-REACTIVE PROTEIN REAGENT

    MDR report key: 976703 · Received January 7, 2008

    Report

    Report Number
    2050012-2008-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2008
    Date of Event
    December 12, 2007
    Report Date
    January 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DCK
    PMA / PMN Number
    K981638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #S: M709279 AND M709319. ADD'L EXPIRATION DATES: 10/31/2009 AND 11/30/2009. ADD'L MFR DATES: 10/29/2007 AND 11/15/2007. BCI RECENTLY VALIDATED A SWITCH FROM MERCK LATEX TO SERADYN LATEX. TO CONFIRM THE FINDING, 2 MERCK LATEX CRP LOTS AND ALL 4 SERADYN LATEX CRP LOTS WERE USED TO ASSAY SAMPLES THAT GRADUALLY RANGED UPWARD FROM 35 TO 65 MG/DL. THE 4 SERADYN LOTS BEGIN TO HOOK DOWN TO APPROX 3-7 MG/DL SOMEWHERE BETWEEN 36-65MG/DL. BOTH MERCK LOTS RECOVERED CORRECT VALUES FOR ALL SAMPLES UP THROUGH 65 MG/DL. IN ADDITION, IT WAS NOTED THAT CRP REAGENT WITH SERADYN LATEX LOT NUMBER 1450 HOOKS AT A MUCH LOWER LEVEL THAN DOES CRP REAGENT WITH SERADYN LATEX LOT NUMBER 112161. CRP REAGENT IS INTENDED FOR THE QUANTITATIVE DETERMINATION OF CRP IN HUMAN SERUM OR PLASMA BY RATE NEPHELOMETRY AND THE MEASUREMENT AIDS IN EVALUATION OF STRESS, TRAUMA, INFECTION, INFLAMMATION, AND SURGERY. A CAPA HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THE ISSUE. BCI WILL INITIATE A PRODUCT CORRECTIVE ACTION (PCA) REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    DURING AN INTERNAL STUDY AT BECKMAN COULTER INC. (BCI) MANUFACTURING CENTER IN CARLSBAD, IT WAS DISCOVERED THAT IMAGE C-REACTIVE PROTEIN (CRP) REAGENT LOTS MADE WITH SERADYN LATEX EXHIBIT A HOOK EFFECT. FURTHER INVESTIGATION REVEALED THAT 4 CRP REAGENT LOTS ARE AFFECTED (3 RELEASED AND 1 IN-PROCESS) AND THE HOOK EFFECT IS EXHIBITED BETWEEN 36 AND 64 MG/DL, AND THE REPORTED RECOVERY DROPS OFF TO APPROX 3-7MG/DL. NO AFFECT TO PT TREATMENT OR LAB PERSONNEL WAS REPORTED AS THIS EVENT WAS DISCOVERED IN HOUSE AND NO PT RESULTS WERE REPORTED FROM THIS LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE C-REACTIVE PROTEIN REAGENT NA DCK BECKMAN COULTER, INC. NA M705441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA