BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CREATINE KINASE

    MDR report key: 7709262 · Received July 21, 2018

    Report

    Report Number
    1628664-2018-00330
    Event Type
    Malfunction
    Date Received
    July 21, 2018
    Report Date
    July 21, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGS
    UDI-DI
    00380740012878
    PMA / PMN Number
    K983070
    Removal / Correction Number
    1628664-07/19/18-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MANUFACTURER REPORT WAS INADVERTENTLY MISSING THE 510K NUMBER, WHICH WAS ADDED TO SECTION PMA/510K (K983070). THERE ARE NO FURTHER UPDATES OR CHANGES.

    Additional Manufacturer Narrative · 1

    A PRODUCT RECALL LETTER WAS ISSUED TO ALL ARCHITECT CUSTOMERS WHO HAVE RECEIVED ARCHITECT CREATINE KINASE, LIST NUMBER 07D63-21, LOT NUMBER 87697UN18. THE LETTER INFORMS THE CUSTOMER OF THE ISSUE REGARDING A STABILITY ISSUE THAT MAY LEAD TO QUALITY CONTROL RESULTS SHIFTING LOW OUT OF RANGE AND/OR ERROR CODE 1054 "UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE" FOR QUALITY CONTROL AND PATIENT SAMPLES. THE LETTER INSTRUCTS THE CUSTOMER TO DISCONTINUE USE OF THE SUSPECT LOTS AND DESTROY ANY REMAINING INVENTORY. THE CAUSE OF THE STABILITY FAILURE HAS BEEN TRACED TO A CONTAMINATION OF THE BULK MATERIAL.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED TRICHOPATHY QUALITY CONTROL SHIFT DOWN ON ALL 3 LEVELS WHEN USING THE CK ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550689 ARCHITECT CREATINE KINASE CREATINE KINASE (CK) CGS ABBOTT MANUFACTURING INC 87697UN18 00380740012878

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000| ARCHITECT C8000| LN 01G06 SN (B)(6)| LN 01G06 SN (B)(6)