BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3222383 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04213
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 21, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN SOUTH (B)(6). THE CUSTOMER WAS ASKED FOR, BUT DID NOT PROVIDE, THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    DUE TO THE LIMITED AMOUNT OF SAMPLE SUPPLIED BY THE CUSTOMER FOR INVESTIGATION NO FURTHER TESTING WAS POSSIBLE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE ANTI-HAV, TOTAL ANTIBODIES (IGM AND IGG) TO HEPATITIS A VIRUS (AHAV) RESULTS WHEN TESTING ONE PATIENT. THE CUSTOMER TESTED BOTH SERUM AND PLASMA THAT WERE DRAWN AT THE SAME TIME ON (B)(6) 2013. THE RESULTS WERE > 60 IU/L IN THE SERUM AND 47.34 IU/L IN THE PLASMA. THE RESULTS FROM AN ARCHITECT ANALYZER WERE 0.20 (CUTOFF: 1.0) FOR ANTI-HAV IGM AND 0.29 (CUTOFF: 1.0) FOR ANTI-HAV IGG. NO UNITS OF MEASURE WERE PROVIDED. THE ROCHE AHAV RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER WAS ASKED WHETHER THE PATIENT WAS HARMED BY THE RESULTS, BUT DID NOT PROVIDE THE INFORMATION. THE LOT NUMBER OF AHAV REAGENT USED WAS 172158. THE CUSTOMER WAS ASKED FOR, BUT DID NOT PROVIDE, THE EXPIRATION DATE. INVESTIGATION OF SERUM AND PLASMA RETURNED TO THE MANUFACTURER CONFIRMED THE INITIAL RESULTS. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323388 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR