BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT MYOGLOBIN REAGENT KIT

    MDR report key: 18896234 · Received March 13, 2024

    Report

    Report Number
    1415939-2024-00027
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 16, 2024
    Report Date
    March 13, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DDR
    UDI-DI
    00380740003302
    PMA / PMN Number
    K042924
    Removal / Correction Number
    1415939-02/27/2024-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION INTO THIS ISSUE FOUND THAT DURING MANUFACTURING, THE MICROPARTICLE CONCENTRATE USED IN REAGENT LOT NUMBER 50808UN23 WAS NOT PROPERLY MIXED. AS A RESULT, AN INSUFFICIENT AMOUNT OF MICROPARTICLES WAS ADDED TO REAGENT LOT 50808UN23. A PRODUCT RECALL LETTER WAS ISSUED ON 21FEB2024 TO ALL CUSTOMERS WHO HAVE RECEIVED SHIPMENTS OF ARCHITECT STAT MYOGLOBIN REAGENT LOT NUMBERS 50808UN23. THE PRODUCT RECALL LETTER NOTIFIES THE CUSTOMER OF THE ISSUE AND THE POTENTIAL IMPACT TO PATIENT RESULTS WITH USE OF LOT 50808UN23. THE PRODUCT RECALL LETTER INSTRUCTS CUSTOMERS TO DISCONTINUE USE OF AND DESTROY ANY REMAINING INVENTORY OF LOT 50808UN23 ACCORDING TO THEIR LABORATORY PROCEDURES AND IMMEDIATELY CONTACT CUSTOMER SUPPORT TO ORDER A REPLACEMENT PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED QUALITY CONTROLS RESULTS WERE OUT OF RANGE LOW WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. FOLLOWING QC DATA WAS PROVIDED. L1 29.6 (20.7¿38.5) L2 89.6 (71.7¿107) L3 227 (182¿273) QC DATA FROM THE IMPACTED LOT AND DIFFERENT LOT 50808UN23 DIFFERENT NEW REAGENT L1 29.6 (20.7¿38.5) 24.0 L2 89.6 (71.7¿107) 76.5 L3 227 (182¿273) 175.2 THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USERS¿ SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192172 ARCHITECT STAT MYOGLOBIN REAGENT KIT MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL DDR ABBOTT LABORATORIES 50808UN23 00380740003302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, I1SR60965