BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFP ¿1-FETOPROTEIN

    MDR report key: 5815708 · Received July 22, 2016

    Report

    Report Number
    1823260-2016-01041
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    July 14, 2016
    Report Date
    October 31, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOJ
    PMA / PMN Number
    K981282
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS CLARIFIED THAT THE RESULTS FROM CUSTOMER B WERE IN A DIFFERENT UNIT OF MEASURE THAN THE RESULTS FROM CUSTOMER A. CUSTOMER A WAS REPORTING AFP RESULTS IN IU/ML. CUSTOMER B WAS REPORTING AFP RESULTS IN UG/L.

    Additional Manufacturer Narrative · 1

    BASED ON THE RECALCULATED DATA PROVIDED BY THE CUSTOMER IN A PREVIOUS FOLLOW-UP REPORT, THE AFP RESULTS BETWEEN CUSTOMER A AND CUSTOMER B WERE COMPARABLE TO ONE ANOTHER. DUE TO THIS, THE INVESTIGATION STATED ANY FALSE INTERPRETATION OF RESULTS CAN BE EXCLUDED. THE DATA PROVIDED CONFIRM THAT THE INITIAL DIFFERENCES BETWEEN THE AFP RESULTS FROM CUSTOMER A AND CUSTOMER B WERE DUE TO AN OPERATOR ERROR. CUSTOMER A WAS REPORTING AFP RESULTS IN IU/ML. CUSTOMER B WAS REPORTING AFP RESULTS IN UG/L. THE OPERATORS DID NOT NOTICE THAT THE AFP RESULTS FOR EACH SITE WERE IN DIFFERENT UNITS OF MEASURE. ONCE THE CONVERSION FACTOR WAS APPLIED TO THE RESULTS, THE ISSUE WITH AFP RESULTS WAS CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IN MEDWATCH REPORT 1823260-2016-00703-00, CUSTOMER A, HAD ISSUES WITH TESTS FOR AFP A1-FETOPROTEIN (AFP) SINCE (B)(6) 2016 WHEN THEY CHANGED TO NEW REAGENT LOT. DURING TROUBLESHOOTING OF THIS ISSUE, PATIENT SAMPLES WERE TESTED AT MULTIPLE SITES ON ROCHE ANALYZERS. AS REPORTED IN FOLLOW UP REPORT 1823260-2016-00703-01, THE INVESTIGATION DETERMINED THE CUSTOMER'S RESULTS AS REPORTED IN MDR 1823260-2016-00703-00 WERE DETERMINED TO BE CORRECT AND THERE MAY BE A POTENTIAL ISSUE AT ONE OF THE SITES WHERE COMPARISON TESTING WAS PERFORMED. THIS MEDWATCH REPORT IS FOR THE SITE IDENTIFIED AS HAVING POTENTIAL ISSUES, WHICH WILL BE REFERRED TO AS CUSTOMER B IN THIS REPORT. DATA WAS PROVIDED FOR 62 PATIENT SAMPLES THAT WERE TESTED FOR AFP AT CUSTOMER B COMPARED TO CUSTOMER A. BASED ON THE DATA PROVIDED, THE RESULTS FOR 10 PATIENT SAMPLES WERE ERRONEOUS. THE AFP RESULTS FROM CUSTOMER B WERE REPORTED OUTSIDE OF THE LABORATORY. CUSTOMER A ALSO RAN 26 PATIENT SAMPLES ON ROCHE ANALYZERS AT 4 DIFFERENT HOSPITAL SITES TO TROUBLESHOOT THE ISSUE WITH THE AFP TEST. BASED ON THE RESULTS FROM THE MULTIPLE COMPARISONS PERFORMED, ERRONEOUS RESULTS FOR 4 PATIENT SAMPLES WERE GENERATED FROM CUSTOMER B. THE RESULTS FROM THE OTHER 3 HOSPITAL SITES WERE COMPARABLE TO ONE ANOTHER. IT IS UNCLEAR WHETHER THE COMPARISON DATA WAS BEING USED FOR TROUBLESHOOTING PURPOSES ONLY OR IF THE AFP RESULTS FROM CUSTOMER B WERE REPORTED OUTSIDE OF THE LABORATORY FOR DIAGNOSTIC PURPOSES. NO ADVERSE EVENT OCCURRED. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468242 AFP ¿1-FETOPROTEIN KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER LOJ ROCHE DIAGNOSTICS NA 133108

    Patients

    Seq Age Sex Outcome Treatment
    1