BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE (LDH)

    MDR report key: 12745826 · Received November 3, 2021

    Report

    Report Number
    3002809144-2021-00630
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 16, 2021
    Report Date
    November 29, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CFJ
    UDI-DI
    00380740161460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR LACTATE DEHYDROGENASE (LDH) LIST NUMBER 2P56-22 LOT 44858UN21. A REVIEW OF TICKETS WAS PERFORMED AND FOUND NO OTHER TICKETS WITH THE SAME ERRATIC RESULTS ISSUE FOR THE REAGENT LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE (LDH) LIST NUMBER 2P56-22 LOT 44858UN21 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    NO IDENTIFIER OR PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER IDENTIFIED FALSELY ELEVATED LACTATE DEHYDROGENASE RESULTS. THE CUSTOMER USES THE REFERENCE RANGE 125U/L TO 243 U/L. THE FOLLOWING INFORMATION WAS PROVIDED: SAMPLE 1 INITIAL RESULT 218 U/L, REPEATED 349 U/L. SAMPLE 2 INITIAL RESULT 606 U/L, REPEATED 838 U/L. THE CUSTOMER NOTED THAT THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND HAVE NOT BEEN QUESTIONED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643528 LACTATE DEHYDROGENASE (LDH) NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ ABBOTT GMBH 2P56-22 44858UN21 00380740161460

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C8 PROC MOD, 01G06-11, C803721| ARC C8 PROC MOD, 01G06-11, C803721