BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT LACTIC ACID

    MDR report key: 6051466 · Received October 24, 2016

    Report

    Report Number
    1628664-2016-00245
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 24, 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
    IL, US
    Reporter Occupation
    OTHER

    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 09D89 IS BEING DISCONTINUED. CUSTOMERS WHO RECEIVE THE FINAL LOTS OF LIST NUMBER 09D89 WILL BE NOTIFIED OF THE INTERFERENCE FROM NAC VIA ADDITIONAL LABELING (KIT STUFFER) CONTAINED WITHIN THE REAGENT KIT. ALL IN-DATE ARCHITECT LACTIC ACID LOT NUMBERS ARE IMPACTED AS FOLLOWS: LIST NUMBER, LOT NUMBER, MANUFACTURE DATE, EXPIRATION DATE: 09D89-21, 31497UN14, 09-DEC-2014, 17-OCT-2016 09D89-21, 09353UN15, 24-MAR-2015, 12-FEB-2017 09D89-21, 45216UN15, 10-JUL-2015, 12-MAY-2017 09D89-21, 14596UN15, 22-SEP-2015, 30-JUL-2017 09D89-21, 37055UN15, 03-DEC-2015, 12-OCT-2017 09D89-21, 14782UN16, 06-JUN-2016, 21-APR-2018

    Description of Event or Problem · 1

    ABBOTT LABORATORIES IDENTIFIED NEGATIVE INTERFERENCE FROM THE DRUG N-ACETYL CYSTEINE (NAC) WITH THE ARCHITECT LACTIC ACID ASSAY. INTERFERENCE RESULTING IN > 10% DEPRESSION IN LACTIC ACID RESULTS WAS OBSERVED AT NAC CONCENTRATIONS OF 1600 MG/L AND SUBSEQUENTLY AT 800 MG/L, BUT NOT AT 80 MG/L. PATIENTS UNDERGOING TREATMENT WITH N-ACETYL CYSTEINE (NAC) MAY HAVE FALSELY DEPRESSED LACTIC ACID RESULTS. A FALSELY DEPRESSED RESULT MAY LEAD A PHYSICIAN TO MISTAKENLY RULE OUT LACTIC ACIDOSIS. NO PATIENT INJURY HAS BEEN REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701527 ARCHITECT LACTIC ACID LACTIC ACID KHP ABBOTT MANUFACTURING INC 31497UN14

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000, C8000 ANALYZERS