BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTATE DEHYDROGENASE (LDH)

    MDR report key: 12915576 · Received December 2, 2021

    Report

    Report Number
    1415939-2021-00051
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 21, 2021
    Report Date
    January 24, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CFJ
    UDI-DI
    00380740004033
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN SECTION D4 CATALOGUE NUMBER, CHANGED FROM 02P56-21 TO 02P56-22.

    Additional Manufacturer Narrative · 0

    A SEARCH BY LOT NUMBER DID NOT FIND ELEVATED COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH LOT 81714UN21 AND THE COMPLAINT ISSUE. THE CUSTOMER FOUND FOAM IN THE BOTTLE AND DETERMINED THAT WAS THE LIKELY CAUSE FOR ELEVATED RESULTS. AS PART OF TROUBLESHOOTING, THE R2 BOTTLE WAS REPLACED, THE SAMPLE WAS RETESTED, AND RESULTS OBTAINED WERE WITHIN RANGE. LABELING WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CC LDH REAGENT LOT 81714UN21 WAS IDENTIFIED.CORRECTED DATA FOUND IN SECTION G1.

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: MULTIPLE = SID (B)(6). 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 OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 125 TO 243 U/L): SID (B)(6) INITIAL RESULT WAS 893 U/L, NO REPEAT RESULT PROVIDED. SID (B)(6) INITIAL RESULT WAS 872 U/L, NO REPEAT RESULT PROVIDED. SID (B)(6) INITIAL RESULT WAS 905 U/L, NO REPEAT RESULT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812569 LACTATE DEHYDROGENASE (LDH) NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ ABBOTT LABORATORIES 2P56-21 81714UN21 00380740004033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C16K PRC MOD, 03L77-01, C1602141| ARC C16K PRC MOD, 03L77-01, C1602141| ARC C16K PRC MOD, 03L77-01, C1602141