BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 4093572 · Received September 16, 2014

    Report

    Report Number
    1823260-2014-07049
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CALIBRATION SEEMED FINE, BUT THE QUALITY CONTROL SHOWED A SLIGHT IMPRECISION. PATIENT TWO WAS A MALE BORN ON (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TINA-QUANT IGG GEN.2 (IGG) ON THEIR P-MODULE. THE FIRST PATIENT'S INITIAL IGG RESULT FROM AN ALIQUOT CUP WAS 22.4 G/L AND IT WAS REPORTED TO THE PATIENT. FOLLOWING A NORMAL ELECTROPHORESIS PATTERN, A REPEAT REQUEST WAS MADE FOR IGG. THE PRIMARY SAMPLE WAS TESTED AND THE RESULT WAS 10.3 G/L. SAMPLE INTEGRITY WAS CHECKED AND FOUND TO BE CLEAR OF ANY VISIBLE CLOTS. THE SAMPLE WAS REPEATED FIVE TIMES FOR A METHOD PRECISION AND THE RESULTS WERE 10.5 G/L, 10.5 G/L, 10.4 G/L, 10.6 G/L, AND 10.5 G/L. ON (B)(6) 2014, THE SECOND PATIENT HAD AN ALIQUOT SAMPLE TESTED AND THE IGG RESULT WAS 15.5 G/L. IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2014 AND THE RESULT WAS 6.1 G/L. INFORMATION ON WHETHER THERE WERE ANY ADVERSE EVENTS WAS REQUESTED BUT NOT PROVIDED. THE IGG REAGENT LOT NUMBER WAS 687298; THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE INSTRUMENT WAS INSPECTED FOLLOWING THE INCIDENTS. THE INSTRUMENT WAS FOUND TO HAVE A HOLE IN THE ACID WASH TUBING AND CRYSTALS HAD FORMED IN THE INSTRUMENT. THE CELLS WERE ALSO NOT BEING WASHED CORRECTLY. MAINTENANCE WAS CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572819 ANALYTICAL P MODULE CLINCAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR