BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS

    MDR report key: 2509487 · Received March 29, 2012

    Report

    Report Number
    1823260-2012-01655
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 29, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE CREATININE PLUS (CREA) RESULTS ON 3 PATIENT SAMPLES. THE RESULTS FOR ALL 3 SAMPLES WERE FOUND TO BE ERRONEOUS. INITIAL TESTING WAS PERFORMED ON (B)(6) 2012, ON THE MODULAR ANALYTICS D MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL CREA RESULT FOR PATIENT 1 WAS 3.3 MG/DL. THE INITIAL CREA RESULT FOR PATIENT 2 WAS 2.1 MG/DL. THE INITIAL CREA RESULT FOR PATIENT 3 WAS 1.8 MG/DL. THE CUSTOMER STATED THE PHYSICIANS QUESTIONED THE INITIAL RESULTS. REPEAT TESTING ON THE SAME SAMPLES WAS PERFORMED ON (B)(6) 2012, ON THE D MODULE WITH SERIAL NUMBER (B)(4) AND THE D MODULE WITH SERIAL NUMBER (B)(4). THE REPEAT TESTING ON D MODULE WITH SERIAL NUMBER (B)(4) IS AS FOLLOWS: THE REPEAT CREA RESULT FOR PATIENT 1 WAS 5.0 MG/DL. THE REPEAT CREA RESULT FOR PATIENT 2 WAS 2.9 MG/DL. THE REPEAT CREA RESULT FOR PATIENT 3 WAS 2.8 MG/DL. THE REPEAT TESTING ON D MODULE WITH SERIAL NUMBER (B)(4) IS AS FOLLOWS: THE REPEAT CREA RESULT FOR PATIENT 1 WAS 4.9 MG/DL. THE REPEAT CREA RESULT FOR PATIENT 2 WAS 2.9 MG/DL. THE REPEAT CREA RESULT FOR PATIENT 3 WAS 2.7 MG/DL. THE CUSTOMER DETERMINED THAT THE REPEAT RESULTS WERE CORRECT, BUT DID NOT INDICATE WHICH OF THE REPEAT RESULTS THEY FOUND TO BE ACCEPTABLE. THE CUSTOMER STATED THE PHYSICIANS DID NOT TREAT THE PATIENTS BASED UPON THE ERRONEOUS RESULTS AND THERE WERE NO ADVERSE EVENTS. THE CREA REAGENT R2 BOTTLE WAS LOT NUMBER (B)(4) WITH AN EXPIRATION DATE OF 04/30/2012. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE CUSTOMER WAS POOLING REAGENTS. THE CUSTOMER REPLACED THE REAGENT AND A SUCCESSFUL CREATININE PRECISION CHECK WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREATININE PLUS ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS NA 65769001

    Patients

    Seq Age Sex Outcome Treatment
    1