BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDL-C PLUS 3RD GENERATION

    MDR report key: 2180032 · Received July 27, 2011

    Report

    Report Number
    1823260-2011-04012
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    November 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LBS
    PMA / PMN Number
    K963213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE ROOT CAUSE WAS INAPPROPRIATE PRE- ANALYTICAL PROCEDURES BY THE USER. THE STORAGE CONDITION, COLLECTION PROCEDURE, CENTRIFUGE TIME AND RPM (G FORCE) FOR PATIENT SAMPLES WERE EVALUATED. THE USER AGREED THERE WERE INAPPROPRIATE PRE-ANALYTICAL PROCEDURES. AS THE VALUES GENERATED AS PART OF THE ISSUE WERE NOT MEDICALLY PLAUSIBLE AND THE IMPLAUSIBILITY CAN BE RECOGNIZED, A MEDICAL RISK RELATED TO THIS EVENT WAS NOT LIKELY.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE HDL RESULTS FROM THE ANALYTICAL P MODULE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 1 AND THE REPEAT RESULT WAS 61. PATIENT SAMPLE 2 INITIAL RESULT WAS 1 AND THE REPEAT RESULT WAS 40. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENTS WERE ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDL-C PLUS 3RD GENERATION LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL LBS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1