BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2

    MDR report key: 6995874 · Received November 2, 2017

    Report

    Report Number
    1823260-2017-02506
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    May 22, 2017
    Report Date
    December 12, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFJ
    PMA / PMN Number
    K964457
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING 2 STATEMENTS IN PRODUCT LABELING APPLY TO THE CUSTOMER'S ISSUE: CONTAMINATION WITH ERYTHROCYTES WILL ELEVATE RESULTS, BECAUSE THE ANALYTE LEVEL IN ERYTHROCYTES IS HIGHER THAN IN NORMAL SERA. THE LEVEL OF INTERFERENCE MAY BE VARIABLE DEPENDING ON THE CONTENT OF ANALYTE IN THE LYSED ERYTHROCYTES. PLASMA FROM PRIMARY TUBES HANDLED ACCORDING TO THE MANUFACTURER¿S INSTRUCTION CAN STILL CONTAIN CELLS, LEADING TO IMPLAUSIBLY HIGH RESULTS. CELL DEBRIS AT THE TOP OF THE SAMPLE LEADING TO THE PHENOMENON DESCRIBED IN PRODUCT LABELING IS THE MOST REASONABLE ROOT CAUSE FOR THE ISSUE. THE FOLLOWING MEDWATCH FIELDS HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 (LDH) ON A COBAS C 111 (C111). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 221 U/L. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER OF UNKNOWN TYPE AT A DIFFERENT LABORATORY AND THE RESULT WAS 119 U/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE LDH REAGENT LOT NUMBER WAS 197423. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775155 LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 LACTATE DEHYDROGENASE TEST SYSTEM CFJ ROCHE DIAGNOSTICS C111 197423

    Patients

    Seq Age Sex Outcome Treatment
    1