BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1833997 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05431
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 18, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATA PROVIDED INDICIATED ALL CONTROL LEVELS RECOVERED ACCEPTABLY. ON THE BASIS OF THE CONTROL RECOVERY AND INVESTIGATION OF THE RETURNED SAMPLES IT CAN BE CONCLUDED THAT THE ONLINE PHENYTOIN APPLICATION IS PERFORMING ACCEPTABLY ON THE MODULAR P ANALYZER. THE EXTREMELY LOW PHENYTOIN RECOVERIES FOR THE PATIENT DRAWS (BELOW 0 UG/ML) ARE DUE TO NON-SPECIFIC AGGLUTINATION PRODUCED BY SOME UNKNOWN COMPONENT PRESENT IN THE PATIENT SAMPLE. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING. NO ADVERSE EVENTS IN RELATION TO THE FALSELY LOW PHENYTOIN RESULT WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR PHENYTOIN ON THE ANALYTICAL P MODULE FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FOR PHENYTOIN WAS 0.0 UG/ML. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER WHICH GAVE A RESULT OF 0.0 UG/ML. BOTH THE INITIAL AND REPEAT RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE USER SAID PER THEIR LAB POLICY, IF A PHENYTOIN RESULT IS < 0.6 UG/ML, THEN THEY WILL REPORT OUT A RESULT OF < 0.6 UG/ML. THE USER REPORTED OUTSIDE THE LABORATORY A PHENYTOIN RESULT OF < 0.6 UG/ML FOR THIS PATIENT SAMPLE. THE USER SENT AN ALIQUOT OF THIS SAMPLE TO ANOTHER FACILITY FOR REPEAT ANALYSIS ON AN INTEGRA ANALYZER. THE REPEAT PHENYTOIN RESULT WAS 36.0 UG/ML. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THESE DISCREPANCIES. THE USER DECLINED A FIELD SERVICE DISPATCH. USER SAID THEY BELIEVED THIS INCIDENT TO BE PATIENT SAMPLE RELATED. THE PHENYTOIN REAGENT LOT NUMBER WAS 14829200. THE USER SAID PATIENT SAMPLE IS AVAILABLE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR