BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE ACC. IFCC VER.2

    MDR report key: 20310638 · Received September 26, 2024

    Report

    Report Number
    1823260-2024-02788
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 3, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFJ
    UDI-DI
    07613336121368
    PMA / PMN Number
    K964457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LDHI2 REAGENT EXPIRATION WAS NOT PROVIDED. THE ALB2 REAGENT LOT NUMBER WAS 786524. THE EXPIRATION WAS NOT PROVIDED. THE COBAS C503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ALARM TRACE ON (B)(6)2024 WAS ACCEPTABLE. A HARDWARE CHECK AND PRECISION STUDIES WERE PERFORMED AND THEY WERE WITHIN SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A PREANALYTICAL HANDLING ISSUE (IT IS UNCLEAR WHETHER A 5- OR 10-MINUTE CENTRIFUGATION PROGRAM WAS USED). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ALBUMIN GEN.2 (ALB2) ASSAY AND LDHI2 ASSAY ON COBAS C503 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE LDHI2 RESULTS. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ALB2 ASSAY. ALB2: INITIAL RESULT: 1.18 G/DL. REPEAT RESULT: 3.63 G/DL. LDHI2: INITIAL RESULT: 380 U/L. REPEAT RESULT: 607 U/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT OF THE ALB2 AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND THE SAMPLE WAS THEN REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304371 LACTATE DEHYDROGENASE ACC. IFCC VER.2 LACTATE DEHYDROGENASE TEST SYSTEM CFJ ROCHE DIAGNOSTICS 785535 07613336121368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown