BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION

    MDR report key: 6928677 · Received October 9, 2017

    Report

    Report Number
    1823260-2017-02223
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 18, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LBS
    PMA / PMN Number
    K012286
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE EVENT OCCURRED IN: (B)(6).

    Additional Manufacturer Narrative · 1

    THE REMAINING PATIENT SAMPLES WERE INSUFFICIENT AND WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. DUE TO THE PATIENT SAMPLES BEING UNAVAILABLE AND THE CLINICAL PICTURE FOR THE PATIENTS NOT BEING PROVIDED IT WAS NO POSSIBLE TO DETERMINE WHICH RESULTS TO BE CORRECT. A LIPID PROFILE OF THE SAMPLES WAS NOT POSSIBLE. THERE WERE NO FIBRIN CLOTS OBSERVED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF HIGH HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDLC3) RESULTS FOR 3 PATIENT SAMPLES. WHEN COMPARING THE RESULTS FROM TWO COBAS 6000 C (501) MODULES (C501) AGAINST THE RESULTS FROM AN ABBOTT SYSTEM, THE RESULTS DID NOT CORRELATE. THE RESULTS FOR TWO OF THE PATIENT SAMPLES WERE A REPORTABLE MALFUNCTION. FOR SAMPLE 1 THE INITIAL HDLC3 RESULT FROM C501 (ANALYZER A) WAS 149 MG/DL WITH A REPEAT DILUTED RESULT OF 159 MG/DL USING HDLC3 REAGENT LOT NUMBER 163062. THE SAMPLE WAS RUN ON ANOTHER C501 (ANALYZER B) WITH AN INITIAL RESULT OF 147 MG/DL AND A REPEAT DILUTED RESULT OF 166 MG/DL USING HDLC3 REAGENT LOT NUMBER 201693 WITH EXPIRATION DATE OF 30-SEP-2018. THE ABBOTT RESULT FOR THE SAME SAMPLE WAS 45 MG/DL AND WAS BELIEVED TO BE CLINICALLY CORRELATING. FOR SAMPLE 2 THE INITIAL HDLC3 RESULT FROM ANALYZER A WAS 156 MG/DL WITH A REPEAT DILUTED RESULT OF 177 MG/DL USING HDLC3 REAGENT LOT NUMBER 163062. THE SAMPLE WAS RUN ON ANALYZER B WITH AN INITIAL RESULT OF 141 MG/DL AND A REPEAT DILUTED RESULT OF 149 MG/DL USING HDLC3 REAGENT LOT NUMBER 201693. THE ABBOTT RESULTS FOR THE SAME SAMPLE WERE 28 MG/DL AND 29 MG/DL AND WERE BELIEVED TO BE CLINICALLY CORRELATING. THE RESULTS FROM ANALYZER A AND ANALYZER B WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE QC RESULTS ON THE BOTH ANALYZER A AND ANALYZER B WERE IN RANGE ON THE DAY OF EVENT. ANALYZER A SERIAL NUMBER WAS 16V9-08 AND ANALYZER B SERIAL NUMBER WAS 16Z0-06. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708852 HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION CHOLESTEROL VIA ESTERASE-OXIDASE, HDL LBS ROCHE DIAGNOSTICS NA 163062

    Patients

    Seq Age Sex Outcome Treatment
    1