BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1863499 · Received October 11, 2010

    Report

    Report Number
    1823260-2010-06031
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 8, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS FOR 1 PATIENT ON THE COBAS ANALYTICAL E MODULE FOR THE INTACT HUMAN CHORIONIC GONADOTROPIN + BETA- SUBUNIT (HCG+BETA) ASSAY. THE CUSTOMER STATED THAT THEY OBTAINED AN INITIAL HCG+BETA RESULT OF 0.1 MIU/ML WITH A DATA FLAG, WHICH WAS REPORTED OUTSIDE THE LABORATORY. REPEAT TESTING YIELDED A RESULT OF 76 MIU/ML WITH A DATA FLAG, WHICH WAS REPORTED OUTSIDE THE LABORATORY AS A CORRECTED REPORT. THERE WAS NO ALLEGATION OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE LOT NUMBER OF HGC+BETA REAGENT WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR