BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1915596 · Received December 6, 2010

    Report

    Report Number
    1823260-2010-07175
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 19, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE POSITIVE ELECSYS (B)(6) RESULT FROM (B)(6) 2010 FOR THIS PATIENT SAMPLE WAS REPRODUCIBLE WITH THE ELECSYS (B)(6) ASSAY. THE ORTHOSAVE ASSAY, RIBA AND PCR ASSAYS WERE FOUND TO BE NEGATIVE. THE POSITIVE RESULT IS REGARDED AS A FALSE POSITIVE. PRODUCT LABELING STATES, "NON-SPECIFIC RESULTS CANNOT BE RULED OUT WITH THE ELECSYS (B)(6) ASSAY". SINGLE FALSE POSITIVE RESULTS CAN OCCUR AND ARE WITHIN THE SPECIFICITY OF 99.71% BLOOD DONORS RESPECTIVELY 99,17% (HOSPITALIZED PATIENTS, DIALYSIS PATIENTS AND PREGNANT WOMAN)." THE REPEATEDLY NEGATIVE RESULTS PRODUCED IN THE CUSTOMER'S LAB WERE CLEARLY NOT A FALSE NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE (B)(6) RESULTS FOR ONE PATIENT BORN IN (B)(6). THE PATIENT HAD BEEN TESTED IN (B)(6) 2010 AND THE (B)(6) RESULT WAS POSITIVE. NO SPECIFIC DATA FOR THIS RESULT WAS PROVIDED. DUE TO A "TRAUMA- SURGERY", ON (B)(6) 2010, TWO SAMPLES WERE DRAWN FROM THE PATIENT. ONE SAMPLE WAS TESTED ON THE ELECSYS ON (B)(6) 2010 AND THE RESULT WAS 0.172 (B)(6) (NEGATIVE). THE SECOND SAMPLE WAS SENT TO AN EXTERNAL LAB AND TESTED ON THE E MODULE ON (B)(6) 2010. THE RESULT WAS 1.51 (B)(6) (POSITIVE). THE USER WAS UNSURE OF THE RESULTS AND RETESTED THE SAMPLE ORIGINALLY TESTED ON THE ELECSYS. THE RESULT WAS AGAIN NEGATIVE. THE USER THEN TESTED ANOTHER SAMPLE FROM THE PATIENT DRAWN ON THE SAME DAY AND THE RESULT WAS NEGATIVE. NO SPECIFIC DATA FOR THESE RESULTS WERE PROVIDED ON (B)(6) 2010, THE FIELD APPLICATION SPECIALIST VISITED THE LABORATORY AND TESTED A NEW SAMPLE FROM THE PATIENT WITH A RESULT OF 0.218 (NEGATIVE). ON (B)(6) 2010, THE USER TESTED THE SAMPLE FROM (B)(6) 2010 WITH A NEW REAGENT FROM THE SAME LOT AND THE RESULT WAS 1.64 (POSITIVE). A CONFIRMATION TEST WAS PERFORMED AT AN EXTERNAL LAB ON THE SAMPLE WHICH INITIALLY GENERATED THE RESULT OF 1.51 (B)(6) (POSITIVE). THE RESULT BY PCR (POLYMERASE CHAIN REACTION) WAS NEGATIVE. THE NEGATIVE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE (B)(6) REAGENT LOT NUMBER WAS 158199.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR