BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 3197116 · Received June 28, 2013

    Report

    Report Number
    1823260-2013-03956
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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 REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR APPROXIMATELY TWENTY PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS. OF THE TWENTY SAMPLES, ONE WAS FOUND TO HAVE AN ERRONEOUS CHOLESTEROL RESULT. THE SAMPLE INITIALLY RESULTED AS 61.0 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED BASED ON THE "ABSURD" LDL CALCULATION THAT WAS SEEN ON A REPORT. THE REPEAT WAS PERFORMED ON A COBAS 6000 ANALYZER, RESULTING AS 222.8 MG/DL. THE SAMPLE WAS REPEATED A SECOND TIME AND RESULTED AS 221.1 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. IT IS UNKNOWN IF THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. NO ADVERSE EVENTS WERE ALLEGED. THE CHOLESTEROL REAGENT LOT NUMBER WAS 67447001 WITH AN EXPIRATION DATE OF 03/31/2014. THE FIELD SERVICE REPRESENTATIVE STATED THAT PRECISION CHECKS OF MULTIPLE ASSAYS INCLUDING GLUCOSE, CHOLESTEROL, ALT, CALCIUM, AND TRIGLYCERIDES WERE FOUND TO BE BORDERLINE. A SAMPLING ISSUE WAS SUSPECTED. HE CHECKED THE RINSE AND VACUUMING OF RINSE MECHANISMS; THESE WERE OK. HE CHECKED THE GEAR PUMP AND VACUUM PRESSURES; THESE WERE OK. HE CHECKED THE STIRRERS AND THESE WERE OK. HE REPLACED THE SAMPLE PROBE AND THEN RERAN PRECISION CHECKS AND ALL WERE WITHIN SPECIFICATION. ALL MECHANICAL CHECKS WERE OK. THE CUSTOMER RAN QUALITY CONTROLS AND THESE WERE OK. THE CUSTOMER WILL CONTINUE TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295013 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1