BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE REAGENT

    MDR report key: 4367896 · Received December 29, 2014

    Report

    Report Number
    9680746-2014-00003
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGX
    PMA / PMN Number
    K934361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE PATIENT'S AGE, DATE OF BIRTH AND WEIGHT FOR THIS EVENT. THE CUSTOMER PROVIDED A REACTION MONITOR FROM THE AU5800 CLINICAL CHEMISTRY ANALYZER FOR REVIEW AND ANALYSIS INDICATES THAT THE GENERATED RESULT IS A TRUE LOW CREATININE RESULT. THERE IS NO EVIDENCE OF ANY MIXING, SAMPLING OR PHOTOMETRY ERRORS. THE CUSTOMER DID NOT REQUEST FOR SERVICE AND NO PARTS WERE REPLACED ON THE INSTRUMENT. THE EVENT ONLY AFFECTED ONE (1) PATIENT SAMPLE. IN CONCLUSION, THE CAUSE OF THE EVENT IS UNKNOWN AND THERE IS NO EVIDENCE OF A MALFUNCTION OF THE AU5800 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO INDICATION THAT CREATININE REAGENT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ERRONEOUSLY LOW CREATININE RESULT FOR ONE (1) PATIENT FROM THE AU5800 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER STATED THAT AN INITIAL CREATININE RESULT OF 114 UMOL/L WAS GENERATED FROM THE AU5800 CLINICAL CHEMISTRY ANALYZER. SUBSEQUENT REPEAT OF THE SAME SAMPLE ON AN ALTERNATE ANALYZER (HITACHI) GENERATED A RESULT OF 202 UMOL/L. THE CUSTOMER STATED THAT THE AU RESULT IS NOT IN ALIGNMENT WITH THE PATIENT'S CLINICAL DIAGNOSIS. THE CUSTOMER STATED THAT CALIBRATION AND QUALITY CONTROL RESULT FOR CREATININE WERE NORMAL AT THE TIME OF THE EVENT. THE CREATININE REAGENT WAS USED IN CONJUNCTION WITH THE AU5800 CLINICAL CHEMISTRY ANALYZER FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856258 CREATININE REAGENT ALKALINE PICRATE, COLORIMETRY, CREATININE CGX BECKMAN COULTER NA 6241

    Patients

    Seq Age Sex Outcome Treatment
    1