BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON CREATININE

    MDR report key: 2063021 · Received April 19, 2011

    Report

    Report Number
    1823260-2011-02102
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED CONCERNING THE EVENT. THE DATE OF THE EVENT WAS (B)(6) 2011. BOTH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. BASED ON THE CREATININE RESULTS AND THE ANAMNESIS, THE PATIENT WAS HOSPITALIZED. BECAUSE THE DIAGNOSIS WAS UNCLEAR, THE PATIENT LEFT THE HOSPITAL AFTER ONE DAY. THE PATIENT'S CURRENT CONDITION WAS GIVEN AS FINE. THE DATE RECEIVED BY MANUFACTURER WAS (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS NONE OF THE CUSTOMER MATERIAL WAS RETURNED AND NO PATIENT SAMPLES WERE AVAILABLE. MATERIAL FROM THE SAME LOT PERFORMED AS SPECIFIED AND NO MALFUNCTION WAS DETECTED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CREATININE RESULTS WHEN COMPARING TWO DIFFERENT SAMPLE TYPES ON THE REFLOTRON SPRINT 220V SERIAL NUMBER 3005496. THE RESULT WITH SERUM DRAWN BY VENIPUNCTURE WAS 48.7 UMOL/L AND THE RESULT WITH EDTA PLASMA IN A MICROTAINER FROM A CAPILLARY DRAW WAS 144 UMOL/L. NO ADVERSE EFFECTS WERE ALLEGED REGARDING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLOTRON CREATININE ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS NA 2029601

    Patients

    Seq Age Sex Outcome Treatment
    1 PLAVIX| SERETIDE AEROSOL| LITALIR