BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 5883287 · Received August 17, 2016

    Report

    Report Number
    1823260-2016-01222
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 17, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.100 MUI/ML. THE REPEAT RESULT ON ANOTHER MODULAR ANALYZER WAS 1188 MUI/ML. ON (B)(6) 2016, THE REPEAT RESULT ON ANOTHER MODULAR ANALYZER WAS 1430 MUI/ML. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 190280. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A POSSIBLE ROOT CAUSE WAS ASSUMED TO BE A SAMPLE-RELATED ISSUE RESULTING IN MISPIPETTING. EXAMPLES INCLUDE A LOW SAMPLE VOLUME IN COMBINATION WITH THE TUBE NOT PLACED STRAIGHT, A MISADJUSTED PROBE, THE NON-USE OF THE RECOMMENDED SAMPLE TUBE RACK ADAPTER, CLOTS OR FIBRIN IN THE SAMPLE, OR BUBBLES. BASED ON THE PROVIDED DATA, THERE WAS NO HINT TO GENERIC REAGENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533905 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR