BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE (LDH)

    MDR report key: 12532492 · Received September 27, 2021

    Report

    Report Number
    3002809144-2021-00581
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 29, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CFJ
    UDI-DI
    00380740161460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. TRENDING REVIEW DETERMINED NO RELATED TRENDS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LIST NUMBER AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LIST NUMBER WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF LACTATE DEHYDROGENASE (LDH) ASSAY, LIST NUMBER 02P56-22, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. REPORTER PHONE COMPLETE ENTRY = (B)(6). REPORTER POSTAL CODE HAD LEADING ZERO ADDED TO MEET MINIMUM FIELD REQUIREMENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT FOR ONE PATIENT ON AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 125-220 U/L): INITIAL RESULT WAS 491, REPEATS WERE 200 AND 212 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432097 LACTATE DEHYDROGENASE (LDH) NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ ABBOTT GMBH 2P56-22 00380740161460

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C8 PROC MOD, 01G06-11, C803904| ARC C8 PROC MOD, 01G06-11, C803904