BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1631069 · Received March 16, 2010

    Report

    Report Number
    1823260-2010-01617
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 24, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFM
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT DETERMINED THE PRECIPITATE IN THE R2 REAGENT DID NOT AFFECT THE RESULTS. THE PRECIPITATE IN THE R2 REAGENT IS A KNOWN PHENOMENON AND IS DESCRIBED IN THE PACKAGE INSERT. AN INSTRUMENT ISSUE COULD BE EXCLUDED BASED ON THE QUALITY CONTROL BEING WITHIN THE EXPECTED RANGE. A PIPETTING ISSUE, WHICH MIGHT HAVE BEEN CAUSED BY PRE-ANALYTICS ISSUE WAS ASSUMED TO THE REASON FOR THE EVENT.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 91 MG/DL AND 45 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT SHE HAD SOME HYPOGLYCEMIC SYMPTOMS AND SELF-TREATED WITH FOOD AND DRINK. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    THE USER STATED THAT A SAMPLE RUN FOR A STANDARD NEWBORN TOTAL BILIRUBIN TEST GAVE A RESULT OF 23.0 MG/DL WITH DATA FLAG. THE RESULT WAS REPORTED AND WAS QUESTIONED BY THE DOCTOR. THE ANALYZER AUTOMATICALLY REPEATED THE SAMPLE WITH A RESULT OF 12.1 MG/DL. THE USER ALSO MANUALLY REPEATED THE SAME SAMPLE IN THE SAME CUP AND IT GENERATED A RESULT OF 12.1 MG/DL WITH DATA FLAG. THE USER GENERATED A CORRECTED REPORT WITH VALUE OF 12.1 MG/DL. THE PATIENT WAS NOT AFFECTED BY THE FIRST RESULT AS THE DOCTOR CALLED TO CHECK THE RESULT. THE TOTAL BILIRUBIN REAGENT LOT NUMBER WAS 61734901 THE USER STATED THEY FOUND LARGE AND SMALL PARTICLES AND A YELLOW DISCOLORATION IN THE R2 REAGENT. THE FIELD SERVICE REPRESENTATIVE CONFIRMED THE CAUSE WAS THE PARTICLES AND YELLOW COLOR IN THE R2 REAGENT. HE CHECKED THE SAMPLE AND REAGENT SYSTEMS FOR PROPER OPERATION AND CHECKED THE RINSE MECHANISM OPERATION. THE USER REPLACED THE REAGENT. TO VERIFY THE ANALYZER OPERATION, A PRECISION TEST WAS PERFORMED WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINCAL CHEMISTRY ANALYZER JFM ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 026 DA