BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE

    MDR report key: 10146006 · Received June 11, 2020

    Report

    Report Number
    3002809144-2020-00471
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    January 29, 2020
    Report Date
    July 3, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    CFG
    UDI-DI
    00380740161477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D. SUSPECT MEDICAL DEVICE WAS DISCOVERED ON (B)(6) 2020. THE CATALOG# WAS SUBMITTED AS 02P56-42 (WIESBADEN, GERMANY MANUFACTURING SITE) BUT SHOULD BE 02P56-21 (IRVING, TEXAS MANUFACTURING SITE). SEE MDR # 1628664-2020-00079 FOR THE CORRECT MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF TRENDING DATA, A REVIEW OF PRODUCT QUALITY HISTORY, AND A REVIEW OF PRODUCT LABELING. THE TICKET SEARCHES DETERMINED THERE WERE NO OTHER COMPLAINTS SIMILAR TO THE CURRENT COMPLAINT ISSUE AND THE TRACKING AND TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO RELATED TRENDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT LDH RESULT OF 337 U/L WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 151 U/L ON THE SAME ARCHITECT ANALYZER AND 132/136 U/L ON A DIFFERENT ARCHITECT ANALYZER. THE CUSTOMER'S NORMAL RANGE IS 125 TO 220 U/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605869 LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFG ABBOTT GMBH 2P56-42 04294UN19 00380740161477

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 ANALYZER| ARCHITECT C16000 ANALYZER| LN 03L77-01 SN (B)(4)| LN 03L77-01 SN (B)(6)