BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS

    MDR report key: 2404721 · Received January 9, 2012

    Report

    Report Number
    1823260-2012-00160
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    December 8, 2011
    Report Date
    May 30, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    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).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMAITON WAS NOT PROVIDED FOR FURTHER INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW CREATININE RESULTS FOR APPROXIMATELY 17% OF THEIR PATIENT SAMPLES FROM BOTH ANALYTICAL P MODULE ANALYZERS. THE ISSUE WAS DISCOVERED WHEN THE LABORATORY RECEIVED COMPLAINTS FROM THE TEST REQUESTORS IN A CLINIC ON (B)(6) 2012. OF THE DATA PROVIDED FOR 27 PATIENT SAMPLES, THE RESULTS FOR 10 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN UMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 83 AND THE REPEAT RESULT WAS 166. PATIENT SAMPLE 2 INITIAL RESULT WAS 38 AND THE REPEAT RESULT WAS 87. PATIENT SAMPLE 3 INITIAL RESULT WAS 36 AND THE REPEAT RESULT WAS 80. PATIENT SAMPLE 4 INITIAL RESULT WAS 112 AND THE REPEAT RESULT WAS 463. PATIENT SAMPLE 5 INITIAL RESULT WAS 126 AND THE REPEAT RESULT WAS 203. PATIENT SAMPLE 6 INITIAL RESULT WAS 166 AND THE REPEAT RESULT WAS 253. PATIENT SAMPLE 7 INITIAL RESULT WAS 359 AND THE REPEAT RESULT WAS 551. PATIENT SAMPLE 8 INITIAL RESULT WAS 46 AND THE REPEAT RESULT WAS 98. PATIENT SAMPLE 9 INITIAL RESULT WAS 52 AND THE REPEAT RESULT WAS 105. PATIENT SAMPLE 10 INITIAL RESULT WAS 47 AND THE REPEAT RESULT WAS 83. ALL OF THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT WAS UNKNOWN IF THE PATIENTS WERE ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE MODULAR PEE WAS (B)(4). THE SERIAL NUMBER OF THE MODULAR PPE WAS (B)(4). THE SERIAL NUMBER OF ONE OF THE ANALYTICAL P MODULE ANALYZERS WAS (B)(4). THE SERIAL NUMBER OF THE OTHER ANALYTICAL P MODULE ANALYZER WAS NOT PROVIDED. THE CREATININE PLUS R2 REAGENT LOT NUMBER WAS 650605. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE GEARPUMP AND PERFORMED A PHOTOMETER CHECK WHICH WAS ACCEPTABLE. HE WASHED THE REAGENT LINES/TUBES, OPTIMIZED THE RINSE UNIT AND PROBE SETTINGS. TO VERIFY THE ANALYZER OPERATION, CALIBRATIONS AND QUALITY CONTROL WERE PERFORMED WHICH WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREATININE PLUS ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS NA 652719

    Patients

    Seq Age Sex Outcome Treatment
    1