BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE (LDH)

    MDR report key: 11077031 · Received December 28, 2020

    Report

    Report Number
    3002809144-2020-01212
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    December 9, 2020
    Report Date
    January 20, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CFJ
    UDI-DI
    00380740161460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF SIMILAR COMPLAINT TICKETS COULD NOT BE PERFORMED AS THE LDH REAGENT LOT NUMBER WAS UNKNOWN. TRENDING REVIEW DETERMINED NO TRENDS FOR FALSELY ELEVATED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE PATIENT SAMPLE WAS RETESTED ON THE SAME INSTRUMENT AND ACCEPTABLE RESULTS WERE GENERATED. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE (LDH) REAGENT, LIST NUMBER 2P56 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 (B)(6) INITIAL LDH ON SERIAL NUMBER (B)(4) (NORMAL RANGE 125-220U/L) / RETEST ON SN (B)(4). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542036 LACTATE DEHYDROGENASE (LDH) NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ ABBOTT GMBH 2P56-22 00380740161460

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C16K PRC MOD, 03L77-01, C1600600| ARC C16K PRC MOD, 03L77-01, C1600600| ARC C16K PRC MOD, 03L77-01, C1600600