BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 3172514 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03616
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CREATININE (CREA), ALANINE AMINOTRANSFERASE ACC. TO (B)(6) WITH/WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT), BILIRUBIN, ALBUMIN, AND AMYLASE ON THEIR P-MODULE. THE CUSTOMER PROVIDED DATA FORM 23 PATIENTS, 16 OF WHICH HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE FIRST PATIENT'S INITIAL CREA RESULT WAS 90 UMOL/L. THE REPEAT RESULT WAS 62 UMOL/L. THE SECOND PATIENT'S INITIAL CREA RESULT WAS 226 UMOL/L. THE REPEAT RESULT WAS 122 UMOL/L. THE THIRD PATIENT'S INITIAL CREA RESULT WAS 82 UMOL/L. THE REPEAT RESULT WAS 46 UMOL/L. THE FOURTH PATIENT'S INITIAL CREA RESULT WAS 164 UMOL/L. THE REPEAT RESULT WAS 87 UMOL/L. THE FIFTH PATIENT'S INITIAL CREA RESULT WAS 81 UMOL/L. THE REPEAT RESULT WAS 56 UMOL/L. THE SIXTH PATIENT'S INITIAL CREA RESULT WAS 69 UMOL/L. THE REPEAT RESULT WAS 126 UMOL/L. THE SEVENTH PATIENT'S INITIAL CREA RESULT WAS 42 UMOL/L. THE REPEAT RESULT WAS 86 UMOL/L. THE EIGHTH PATIENT'S INITIAL CREA RESULT WAS 276 UMOL/L. THE REPEAT RESULT WAS 417 UMOL/L. THE NINTH PATIENT'S INITIAL ALT RESULT WAS 420 U/L. THE REPEAT RESULT WAS 50 U/L. THE TENTH PATIENT'S INITIAL ALT RESULT WAS 114 U/L. THE REPEAT RESULT WAS 46 U/L. THE ELEVENTH PATIENT'S INITIAL ALT RESULT WAS 345 U/L. THE REPEAT RESULT WAS 162 U/L. THE TWELFTH PATIENT'S INITIAL BILIRUBIN RESULT WAS 112 UMOL/L. THE REPEAT RESULT WAS 15 UMOL/L. THE THIRTEENTH PATIENT'S INITIAL BILIRUBIN RESULT WAS 105 UMOL/L. THE REPEAT RESULT WAS 6 UMOL/L. THE FOURTEENTH PATIENT'S INITIAL BILIRUBIN RESULT WAS 80 UMOL/L. THE REPEAT RESULT WAS 20 UMOL/L. THE FIFTEENTH PATIENT'S INITIAL ALBUMIN RESULT WAS 42 G/L. THE REPEAT RESULT WAS 28 G/L. THE SIXTEENTH PATIENT'S INITIAL ALBUMIN RESULT WAS 44 G/L. THE REPEAT RESULT WAS 28 G/L. IT WAS UNKNOWN IF THERE WERE ANY ADVERSE EVENTS. THE CREA, ALT, BILIRUBIN, AND ALBUMIN REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT NOZZLES 2 AND 6 WERE SUDDENLY OVERFLOWING INTO THE CUVETTES. HE ADJUSTED THE RINSE WATER LEVEL. THE INSTRUMENT WAS WORKING TO SPECIFICATION AND NO FURTHER ISSUES HAD BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273510 ANALYTICAL P MODULE CLINCAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1