BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 2871632 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06315
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 27, 2012
    Report Date
    January 16, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. CALIBRATION AND QUALITY CONTROL WERE GOOD PRIOR TO THE RUN. A PERFORMANCE TEST WAS DONE AND SHOWED NO INDICATION OF AN INSTRUMENT ISSUE. A SERVICE VISIT WAS PERFORMED. A COMPLETE MAINTENANCE WAS DONE AND THE SAMPLE PIPETTOR WAS CHANGED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE (PROBNP) RESULTS ON THEIR ELECSYS 2010 ANALYZER FOR TWO PATIENTS. THE INITIAL PROBNP RESULTS FOR BOTH PATIENTS WERE NOT CONSISTENT WITH THE PATIENTS' CONDITIONS AND NEW MEASUREMENTS WERE REQUESTED. THE FIRST PATIENT'S INITIAL PROBNP RESULT WAS 46.74 PG/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2012, THE SAMPLE WAS REPEATED AND THE RESULT WAS 10207 PG/ML. ON (B)(6) 2012, THE PATIENT HAD A NEW SAMPLE DRAWN AND THE RESULT WAS 7509 PG/ML. ON (B)(6) 2012, THE SECOND PATIENT, AN (B)(6), MALE, HAD AN INITIAL PROBNP RESULT OF 49.51 PG/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2012, THE SAMPLE WAS REPEATED AND THE RESULT WAS 21065 PG/ML. ON (B)(6) 2012, THE PATIENT HAD ANOTHER SAMPLE TUBE TESTED THAT WAS DRAWN AT THE SAME TIME AS THE ORIGINAL SAMPLE AND THE RESULT WAS 21631 PG/ML. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THIS EVENT. THE PROBNP REAGENT LOT NUMBER WAS 168452 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 088 YR