BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 4768809 · Received May 13, 2015

    Report

    Report Number
    1823260-2015-03453
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 9, 2015
    Report Date
    May 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR VITAMIN B12 (B12), FOLATE, AND PARATHYROID HORMONE-PTH, INTACT. OF THE THREE INVOLVED TESTS, THE SAMPLE HAD ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY FOR B12 AND FOLATE. THE PRIMARY CONTAINER OF THE SAMPLE INITIALLY RESULTED AS <22 PMOL/L FOR B12 AND 1.7 NMOL/L FOR FOLATE. AN ALIQUOT OF THE SAMPLE WAS THEN REPEATED ON (B)(6) 2015 AND RESULTED AS 189 PMOL/L FOR B12 AND 8.7 NMOL/L FOR FOLATE. THE PRIMARY CONTAINER OF THE SAMPLE WAS THEN REPEATED ON (B)(6) 2015, RESULTING AS 200.3 PMOL/L FOR B12 AND 10.11 NMOL/L FOR FOLATE. THE ALIQUOT OF THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2015, RESULTING AS 198.5 PMOL/L FOR B12 AND 9.81 NMOL/L FOR FOLATE. THE ALIQUOT OF THE SAMPLE WAS REPEATED AN ADDITIONAL TIME ON (B)(6) 2015, RESULTING AS 192 PMOL/L FOR B12 AND 10.19 NMOL/L FOR FOLATE. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. THE B12 REAGENT LOT NUMBER WAS 183415 AND THE FOLATE REAGENT LOT NUMBER WAS 180514. THE B12 AND FOLATE REAGENT EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE PERFORMED AN ADJUSTMENT CHECK, CHECKED THE LLD VOLTAGE, CLEANED THE PIPETTOR, AND CHECKED THE GEAR PUMP. THE CUSTOMER HAS NOT REPORTED ANY FURTHER INCIDENTS AFTER THE PERFORMED SERVICE ACTIVITIES. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. IT WAS DETERMINED THAT THE CUSTOMER WAS USING A SMALLER 11MM TUBE SIZE, WHICH IS NOT RECOMMENDED FOR USE AND MAY BE A POTENTIAL ROOT CAUSE. A GENERAL REAGENT ISSUE COULD NOT BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313462 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 013 YR