BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3901561 · Received June 30, 2014

    Report

    Report Number
    1823260-2014-04741
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    January 6, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    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

    A ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER'S ELECSYS RESULTS WERE CONFIRMED. STREPTAVIDIN, RUTHENIUM, AND HAMA INTERFERENCE COULD BE EXCLUDED. THE INVESTIGATION RESULTS SHOWED A HIGH DEGREE OF VARIABILITY WHILE THE QUALITY CONTROL RESULTS WERE IN RANGE. THE EFFECT MUST BE SAMPLE SPECIFIC AND DUE TO SOME UNKNOWN INTERFERENCE OR INHOMOGENEITY. FURTHER INVESTIGATION WAS NOT POSSIBLE DUE TO A LACK OF SAMPLE.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR INVESTIGATION. THE PTH RESULTS WITH THE ELECSYS REAGENT WERE FOUND TO BE ABOVE THE REFERENCE RANGE.

    Additional Manufacturer Narrative · 1

    THE PTH REAGENT LOT NUMBER WAS 17526000 AND THE EXPIRATION DATE WAS 04/2015. THE PATIENT HAD AS SERUM SAMPLE DRAWN ON (B)(6) 2014 AND THE PTH RESULT WAS 116 PMOL/L.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLY HIGH PARATHYROID HORMONE (PTH) RESULTS FOR ONE PATIENT ON THEIR E602 ANALYZER. ON (B)(6) 2013, THE PATIENT'S PTH RESULT FROM THE E602 METHOD WAS 120.4 PMOL/L. THE PATIENT HAD ANOTHER SAMPLE DRAWN IN (B)(6) 2013, AND THE PATIENT'S PTH RESULT FROM THE E602 METHOD WAS 120 PMOL/L. ON (B)(6) 2013, ANOTHER SAMPLE HAD A PTH RESULT FROM THE E602 METHOD OF 121 PMOL/L. ON (B)(6) 2013, ANOTHER SAMPLE HAD A PTH RESULT FROM THE E602 METHOD OF 117.8 PMOL/L. ON (B)(6) 2014, ANOTHER SAMPLE HAD A PTH RESULT FROM THE E602 METHOD 117.7 PMOL/L. THE SAMPLE FROM (B)(6) 2014 WAS SENT TO FOR ANALYSIS BY AN ABBOTT METHOD. THE REPEAT RESULT WAS 8.9 PMOL/L. THIS RESULT WAS MORE CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. ON (B)(6) 2014, ANOTHER SAMPLE HAD A PTH RESULT FROM THE E602 METHOD OF 114.8 PMOL/L. THE CUSTOMER STATED THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. AS FAR AS THE CUSTOMER WAS AWARE, THE PATIENT WAS NOT ADVERSELY AFFECTED. NO ACTIONS WERE TAKEN BASED ON THE DISCREPANT RESULTS BECAUSE THE CLINICIAN DID NOT BELIEVE THE RESULTS. THE PTH REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379853 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR CALCICHEW| SENOKOT| FUROSEMIDE| OMEPRAZOLE| THYROXINE| MONTELUKAST| CITALOPRAM| LACTULOSE| TRAMADOL| FOSTAIR| EPILIM| LORATIDINE