BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 2173032 · Received July 23, 2011

    Report

    Report Number
    1823260-2011-03908
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K024098
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION COULD NOT BE PERFORMED AS ADDITIONAL INFORMATION WAS NOT PROVIDED. THE CUSTOMER CHANGED THE SAMPLE PROBE WHICH APPEARED TO RESOLVE THE ISSUE. THE ISSUE HAS NOT RECURRED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CREATININE RESULTS FROM THE COBAS C501 SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. THE INITIAL RESULT WAS 1.0. THE REPEAT RESULT ON ANOTHER COBAS C501 ANALYZER WAS 1.3 WITH A DATA FLAG AND ON ANOTHER COBAS C501 ANALYZER WAS 1.3 WITH A DATA FLAG TWICE. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE USER REFUSED TO PROVIDE INFORMATION CONCERNING IF THE PATIENTS WERE ADVERSELY AFFECTED AS SHE STATED SHE HAD NO WAY TO DETERMINE THIS. NO CORRECTIVE REPORTS WERE GENERATED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDIC FAILURE OF THE SAMPLE PROBE. THE USER REPLACED THE SAMPLE PROBE. TO VERIFY THE ANALYZER OPERATION, THE FIELD SERVICE REPRESENTATIVE RAN CALIBRATION, QUALITY CONTROL AND PERFORMANCE TESTING WITH ALL RESULTS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREATININE PLUS VER.2 ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS NA 64024401

    Patients

    Seq Age Sex Outcome Treatment
    1 088 YR