BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CALCIUM

    MDR report key: 7008823 · Received November 8, 2017

    Report

    Report Number
    1628664-2017-00429
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Report Date
    November 13, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJY
    UDI-DI
    00380740005931
    PMA / PMN Number
    K981578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE OR NON-STATISTICAL TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO NON-CONFORMANCES, DEVIATIONS OR POTENTIAL NON-CONFORMANCES ASSOCIATED WITH THE AFFECTED ASSAY HAVE BEEN IDENTIFIED. THERE WERE NO RETURNS AVAILABLE FROM THE CUSTOMER SITE. A REVIEW OF CUSTOMER INSTRUMENT LOGS FOUND NO EVIDENCE OF ANY ABNORMALITIES THAT MAY HAVE CAUSED THE REPORTED ISSUE. HOWEVER, THE ASSAY GRAPHS BETWEEN THE INITIAL AND RETEST RESULTS WERE VERY DIFFERENT. ALSO, NUMEROUS ASPIRATION ERRORS WERE NOTED. AN OCCURRENCE OF THIS ERROR WITH NO ASSIGNABLE INSTRUMENT CAUSE SUGGESTS AN ISSUE WITH SAMPLE HANDLING AND/OR INTEGRITY. THE HISTORY LOG SHOWS OCCURRENCES OF INSTRUMENT HARD STOPS AFTER WHICH THE REQUIRED CUVETTE WASHING WAS NOT ALLOWED TO OCCUR (CUSTOMER INITIATED). THE ARCHITECT CLINICAL CHEMISTRY CALCIUM (CA) ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A SYSTEMIC ISSUE OR PRODUCT DEFICIENCY EXISTS. USE ERROR MAY HAVE CONTRIBUTED TO THE ISSUE AS IT APPEARS TO BE SAMPLE SPECIFIC. THE CUSTOMER DID MENTION THAT THERE MAY HAVE BEEN CELLS ON TOP OF THE SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE FOLLOWING PATIENT ARCHITECT CLIN CHEM CALCIUM ASSAY RESULTS GENERATED ON AN ARCHITECT C16000 ANALYZER: (B)(6). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788222 CLINICAL CHEMISTRY CALCIUM CALCIUM CJY ABBOTT MANUFACTURING INC 80658UN17 00380740005931

    Patients

    Seq Age Sex Outcome Treatment
    1