BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2963837 · Received February 15, 2013

    Report

    Report Number
    1823260-2013-00905
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    April 26, 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).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE CUSTOMER. THE QUALITY CONTROL AND CALIBRATION DATA WAS ACCEPTABLE. THE ROOT CAUSE APPEARS TO BE RELATED TO A PRE-ANALYTICAL ISSUE. THE CUSTOMER STATED THEY SAW AIR BUBBLES ON THE SURFACE OF SAMPLES AFTER CENTRIFUGATION. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CREATININE PLUS (CREP) RESULTS ON THEIR P-MODULE. THE CUSTOMER PROVIDED DATA FOR 13 PATIENTS, OF WHICH 4 HAD DISCREPANT RESULTS. THE FIRST PATIENT'S INITIAL CREP RESULT WAS 114.3 UMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER P- MODULE, SERIAL NUMBER NOT PROVIDED (P3), AND THE PATIENT'S RESULT WAS CHANGED TO 291.1 UMOL/L. THE SECOND PATIENT'S INITIAL CREP RESULT WAS 124 UMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY.. THE SAMPLE WAS REPEATED ON P3 AND THE PATIENT'S RESULT WAS CHANGED TO 235.7 UMOL/L. THE THIRD PATIENT'S INITIAL CREP RESULT WAS 40.2 UMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY.. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER, ANALYZER TYPE NOT PROVIDED (ALB), AND THE PATIENT'S RESULT WAS CHANGED TO 80 UMOL/L. THE FOURTH PATIENT'S INITIAL CREP RESULT WAS 26.1 UMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND THE RESULT WAS 78.9 UMOL/L. THE SAMPLE WAS REPEATED ON ALB AND THE RESULT WAS 89 UMOL/L. IT WAS UNCLEAR WHICH RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED "THERE HAS NOT BEEN ANY CONTACT FROM THE DEPARTMENT ABOUT THE WRONG RESULTS". IT IS UNKNOWN IF ANY PATIENTS WERE HARMED DUE TO THIS EVENT. THE CREP REAGENT LOT NUMBER PROVIDED WAS "1" AND EXPIRATION DATE WERE NOT PROVIDED. THE SIX MONTH PREVENTATIVE MAINTENANCE HAD BEEN PERFORMED ON THE ANALYZER. THE SAMPLE PROBES WERE THOROUGHLY CLEANED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67052 ANALYTICAL P MODULE CLINCAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1