BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE JAFFÉ GEN.2

    MDR report key: 2190367 · Received August 4, 2011

    Report

    Report Number
    1823260-2011-04180
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K941837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE CUSTOMER STATED THAT THE PHARMACIST INDICATED, BASED ON THE CREATININE RESULTS, THE DOSAGE OF ANTIBIOTICS MAY HAVE BEEN INCREASED. THE PHARMACIST DID NOT PROVIDE ANY SPECIFIC EXAMPLES OR STATE THAT ANY SPECIFIC PATIENT WAS AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE CREATININE RESULTS WHEN TESTING WAS PERFORMED ON THE COBAS 4000 C311 ANALYZER, SERIAL NUMBER (B)(4). INITIAL TESTING WAS PERFORMED (B)(6) 2011 AND REPEAT TESTING WAS PERFORMED (B)(6) 2011 ON THE SAME ANALYZER. BETWEEN THE INITIAL AND REPEAT TESTING THE CUSTOMER HAD RECONFIGURED THE CREATININE ASSAY FROM THE "STAT" APPLICATION TO THE "RATE-BLANKING" APPLICATION. THEREFORE, INITIAL TESTING WAS PERFORMED USING THE STAT APPLICATION AND REPEAT TESTING WAS PERFORMED USING THE RATE-BLANKING APPLICATION. OF 13 SETS OF PATIENT RESULTS PROVIDED, 5 WERE FOUND TO BE DISCREPANT. FOR PATIENT 1, THE INITIAL CREATININE WAS 0.9 MG/DL AND THE REPEAT WAS 1.1 MG/DL. FOR PATIENT 2, THE INITIAL CREATININE WAS 0.7 MG/DL AND THE REPEAT WAS 0.9 MG/DL. FOR PATIENT 3 THE INITIAL CREATININE WAS 0.7 MG/DL AND THE REPEAT WAS 0.9 MG/DL. FOR PATIENT 4, THE INITIAL CREATININE WAS 0.6 MG/DL AND THE REPEAT WAS 0.9 MG/DL. FOR PATIENT 5, THE INITIAL CREATININE WAS 0.7 MG/DL AND THE REPEAT WAS 0.9 MG/DL. THE CUSTOMER STATED THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER CONSIDERS THE REPEAT RESULTS TO BE CORRECT. THE CUSTOMER ALSO STATED PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. THERE WAS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER STATED THE INDIVIDUALS HAVING SPECIFIC PATIENT INFORMATION ARE ON VACATION. ATTEMPTS TO FOLLOW UP FOR MORE INFORMATION WILL BE MADE. THE CUSTOMER BELIEVED THE INITIAL CREATININE RESULTS WERE DUE TO APPLICATION THAT WAS LOADED. THE CUSTOMER DID NOT PRINT OUT THE STAT APPLICATION PARAMETERS PRIOR TO DELETING THE APPLICATION FROM THE SYSTEM, THEREFORE IT IS UNKNOWN IF THE APPLICATION WAS CONFIGURED CORRECTLY. THE CUSTOMER STATED THE ISSUE WAS RESOLVED BY DOWNLOADING THE NEW CREATININE APPLICATION AND DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREATININE JAFFÉ GEN.2 ALKALINE PICRATE, COLORIMETRY, CREATININE CGX ROCHE DIAGNOSTICS NA 64117401

    Patients

    Seq Age Sex Outcome Treatment
    1