BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT LACTIC ACID

    MDR report key: 6133121 · Received November 29, 2016

    Report

    Report Number
    1628664-2016-00291
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 20, 2015
    Report Date
    November 29, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    KHP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1628664-10/11/16-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT LABORATORIES IDENTIFIED NEGATIVE INTERFERENCE FROM THE DRUG N-ACETYL CYSTEINE (NAC) WITH THE ARCHITECT LACTIC ACID ASSAY LEADING TO FALSELY DEPRESSED LACTIC ACID RESULTS. A PRODUCT CORRECTION LETTER WAS ISSUED TO ALL CURRENT ARCHITECT LACTIC ACID CUSTOMERS. THE LETTER INFORMS THE CUSTOMER THAT PATIENTS UNDERGOING TREATMENT WITH N-ACETYL CYSTEINE (NAC) MAY HAVE FALSELY DEPRESSED LACTIC ACID RESULTS. ARCHITECT LACTIC ACID LIST NUMBER (B)(4) IS BEING DISCONTINUED. CUSTOMERS WHO RECEIVE THE FINAL LOTS OF LIST NUMBER (B)(4) WILL BE NOTIFIED OF THE INTERFERENCE FROM NAC VIA ADDITIONAL LABELING (KIT STUFFER) CONTAINED WITHIN THE REAGENT KIT.

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED N-ACETYL CYSTEINE (NAC) INTERFERENCE TESTING WITH SEVERAL ARCHITECT CHEMISTRY ASSAYS IN (B)(6) 2015 AND DISCOVERED INTERFERENCE WITH THE LACTIC ACID ASSAY. NO DISCREPANT ARCHITECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783131 ARCHITECT LACTIC ACID LACTIC ACID KHP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 SYSTEM| LIST (B)(4), SERIAL (B)(4)