BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 6287714 · Received January 30, 2017

    Report

    Report Number
    1628664-2017-00018
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    January 11, 2017
    Report Date
    April 20, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE ACCOUNT AND VERIFIED THE REAR TILT COVER (PART NUMBER 7-203390-01) WAS CORRECTLY INSTALLED AND ALIGNED. NO SUBSEQUENT CONTACTS FROM THE CUSTOMER OCCURRED REGARDING THE ANALYZER COVERS FALLING. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS AND LABELING REVIEW. 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 DEVICE EVALUATION WAS CONCLUDED THAT A MALFUNCTION OCCURRED, THE DEVICE DID NOT PERFORM AS INTENDED. A MALFUNCTION OF THE REAR TILT COVER (PART NUMBER 7-203390-01) WAS IDENTIFIED. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE; HOWEVER, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED AS THIS WAS THE SOLE COMPLAINT FOR THE ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER ITEM EVALUATION SUMMARY ATTACHED SHOULD BE BLANK AND WAS INADVERTENTLY SELECTED (CHECKED). NO EVALUATION INFORMATION WAS CREATED OR ATTACHED TO MANUFACTURER REPORT NUMBER 1628664-2017-00018.

    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

    WHILE THE PUMP AREA OF THE ARCHITECT I2000SR ANALYZER WAS BEING CLOSED, ANOTHER INDIVIDUAL INADVERTENTLY CAME IN CONTACT WITH THE BACK SIDE OF THE ANALYZER AND THE REAR TILT COVER (PART NUMBER 7-203390-01) FLIPPED OPEN, FELL, AND HIT THE CUSTOMER ON THE HEAD. NO INJURY WAS REPORTED AND NO MEDICAL TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70373 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1