BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2016-00224

    MDR report key: 5921256 · Received September 1, 2016

    Report

    Report Number
    1628664-2016-00224
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Report Date
    April 22, 2017
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR REPLACED BOTH THE VALVE, POPPET SET (PART 09D36-02) AND BELLOWS, BELLOWS ONLY (PART 2-89054-02) DURING TROUBLESHOOTING. REPLACEMENT OF THE VALVE, POPPET SET (PART 09D36-02) RESOLVED THE CUSTOMER ISSUE AND WAS DESIGNATED BY THE FSR AS THE LIKELY CAUSE. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND A REVIEW OF INSTRUMENT SERVICE. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE ANALYZER PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THE DEVICE DID NOT PERFORM AS INTENDED. HOWEVER, NO SYSTEMATIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. CONCLUSION CODE IN EVALUATION CODES WAS CORRECTED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM PATIENT RESULTS GENERATED USING THE ARCHITECT C4000 ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED. THE CUSTOMER USES MAGNESIUM NORMAL RANGE 1.6 TO 2.6 MG/DL. PATIENT 1, INITIAL 8.6, REPEAT 1.9; PATIENT 2, INITIAL 9.0 REPEAT 1.9, 2.0. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY MAGNESIUM| LIST NUMBER 07D70-21| LOT NUMBER 26102UN16