BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 7331986 · Received March 12, 2018

    Report

    Report Number
    1823260-2018-00781
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    December 15, 2017
    Report Date
    March 12, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IN (B)(6) 2017, THE CUSTOMER HAD PRECISION ISSUES WITH THE HAPTOGLOBIN TINA-QUANT HAPTOGLOBIN (HAPTOGLOBIN) TEST ON A MODULAR P MODULE. BY THE END OF (B)(6) 2017 THEY HAD INSTALLED EXTRA SPECIAL WASH STEPS WHICH APPEARED TO HAVE SOLVED THE ISSUE. THEN, ON (B)(6) 2017 THEY HAD AN ERRONEOUS HIGH RESULT FOR 1 NEONATE SAMPLE. THE INITIAL RESULT WAS 1.67 G/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS < 0.2 G/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HAPTOGLOBIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CUSTOMER HAS SINCE STOPPED USING THIS INSTRUMENT AND IS NOW USING A COBAS SYSTEM FOR PATIENT TESTING. NO FURTHER INFORMATION RELATED TO THE P MODULE IS AVAILABLE FROM THE CUSTOMER. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173968 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS P MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1