BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE

    MDR report key: 21433608 · Received February 21, 2025

    Report

    Report Number
    1823260-2025-00516
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFJ
    UDI-DI
    04015630926961
    PMA / PMN Number
    K964457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE ALP LOT NUMBER IS 844442. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER PERFORMED HARDWARE AND PRECISION CHECKS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH A HIGH LEUKOCYTE CONCENTRATION IN THE SAMPLES LEADING TO AN ACCUMULATION OF CELLS CLOSE TO THE PLASMA SURFACE. FALSELY HIGH LDH AND ALP VALUES CAN OCCUR IF BLOOD CELLS OR CELL DEBRIS ARE NOT PROPERLY REMOVED IN THE PRE-ANALYTICAL SAMPLING PROCESS. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) AND LACTATE DEHYDROGENASE (LDH) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL ALP RESULT WAS 213 U/L. THE REPEATED RESULTS WERE 148 U/L, 64.8 U/L, 64.6 U/L, AND 170 U/L. THE INITIAL LDH RESULT WAS 419 U/L AND THE REPEATED RESULTS WERE 277 U/L AND 259 U/L. THE LEUKOCYTE VALUES IN THIS SAMPLE WERE IN THE NORMAL RANGE. THIS MEDWATCH WILL APPLY TO THE LACTATE DEHYDROGENASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR INFORMATION RELATED TO THE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269480 LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE TEST SYSTEM CFJ ROCHE DIAGNOSTICS 817145 04015630926961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown