BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE

    MDR report key: 9752912 · Received February 25, 2020

    Report

    Report Number
    1628664-2020-00079
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    January 29, 2020
    Report Date
    July 5, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    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 BUT SHOULD BE 02P56-21 (IRVING, TEXAS MANUFACTURING SITE).

    Additional Manufacturer Narrative · 0

    THIS INCIDENT WAS INADVERTENTLY SUBMITTED UNDER THE INCORRECT SUSPECT MEDICAL DEVICE MANUFACTURING SITE. THE ERROR WAS DISCOVERED ON JUNE 10, 2020. MDR NUMBER 3002809144-2020-00471 WAS SUBMITTED TO CORRECT THE MANUFACTURING SITE FROM IRVING, TEXAS TO WIESBADEN, GERMANY.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION, NO SPECIFIC PATIENT INFORMATION PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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
    215785 LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFG ABBOTT LABORATORIES (IRVING IA/CC) 2P56-42 04294UN19 00380740161477

    Patients

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