BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2235848 · Received September 7, 2011

    Report

    Report Number
    2050012-2011-04955
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JNM
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011, FOR THIS EVENT. THE FSE REPLACED THE REAGENT PROBE, SAMPLE PROBES AND LEVEL SENSE BOARDS FOR PROBES. THE FSE REPLACED THE MIXER PADDLES, AND CUVETTE WASH HEAD. AFTER THE REPAIRS, THE FSE PERFORMED INSTRUMENT PERFORMANCE VERIFICATION ASSESSMENTS WHICH MET SPECIFICATIONS. MDR ASSOCIATED WITH THIS EVENT: 2050012-2011-02578, 2050012-2011-04955.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011, ERRONEOUS PREALBUMIN (PAB) AND/OR TRANSFERRIN (TRF) RESULTS WERE GENERATED ON AN IMMAGE IMMUNOCHEMISTRY SYSTEM FOR MULTIPLE PATIENT SAMPLES. THE EXACT NUMBER OF INVOLVED PATIENT SAMPLES IN UNKNOWN. ALTHOUGH THE CUSTOMER INDICATED THAT IMMUNOGLOBULIN G (IGG) AND C-REACTIVE PROTEIN (CRP) QUALITY CONTROL RESULTS WERE DISCREPANT, THE CUSTOMER DID NOT INDICATE OR PROVIDE EVIDENCE THAT ANY IGG AND CRP PATIENT RESULTS WERE AFFECTED. DATA PROVIDED BY THE CUSTOMER INDICATED THE GENERATION OF ELEVEN PAB RESULTS AND TWO TRF RESULTS. NO EVIDENCE OF DISCREPANT IMMUNOGLOBULIN G (IGG) AND C-REACTIVE PROTEIN (CRP) RESULTS WAS PROVIDED. IN SEVEN CASES, THE REPEAT PAB RESULTS WERE LOWER AND REGARDED VALID. IN BOTH CASES, THE REPEAT TRF RESULTS WERE LOWER AND CONSIDERED VALID. IN ONE CASE, THE REPEAT PAB RESULT WAS HIGHER THAN THE INITIAL PAB RESULT. IN THREE CASES THE PAB INITIAL RESULTS WAS NOT REPEATED AND HENCE THE INITIAL RESULTS WERE NOT CONFIRMED AS ERRONEOUS BY REPEAT TESTING. THE ERRONEOUS INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND HENCE THERE WERE NO DEATHS, SERIOUS INJURIES OR CHANGE TO PATIENTS' TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SAMPLES WERE SERUM. PAB, TRF, IGG AND CRP QUALITY CONTROL (QC) RESULTS DURING THE TIMEFRAME OF THE EVENT WERE "HIGH" UPON INITIAL RUN AS WELL AS ON A RERUN ATTEMPT AFTER IMPLEMENTING NEW REAGENT PACKS AND CONTROLS. AFTER PRIMING THE INSTRUMENT, ALL ASSAY QC RESULTS WERE WITHIN ESTABLISHED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE JNM BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1