BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 7507722 · Received May 11, 2018

    Report

    Report Number
    1628664-2018-00186
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    April 20, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT DATA, FIELD SERVICE REVIEW, A REVIEW OF SERVICE HISTORY, AND A SEARCH FOR SIMILAR COMPLAINTS. RETURN MATERIAL WAS NOT AVAILABLE. AN ABBOTT FIELD SERVICE RE-ROUTED THE CABLE TO PREVENT POSSIBLE RECURRENCE. A REVIEW OF THE ANALYZER SERVICE HISTORY WAS PERFORMED AND NO CONTRIBUTING FACTOR TO THE CURRENT EVENT WAS FOUND. ADDITIONALLY, NO RELATED ISSUES WERE IDENTIFIED FOR THE CABLE, USB A TO B, 10 FT (3 M) (ROHS)_PART NUMBER 7-100417-01 BEFORE OR AFTER THE PART WAS REPLACED. THE CURRENT COMPLAINT IS A SOLE COMPLAINT RELATING TO A PINCHED (SPARK) FOR THE CABLE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT I2000SR ANALYZER, LIST NUMBER 03M74, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT WHEN THEY MOVED THE MONITOR OF THE ARCHITECT I2000SR ANALYZER THEY OBSERVED A SPARK ALONG THE ARM THAT JOINS TO THE MONITOR. THE MONITOR AND CPU BOTH SHUT OFF WHEN THE SPARK OCCURRED. INITIAL WHILE TROUBLESHOOTING OF THE ISSUE, OBSERVED EVIDENCE THAT THE MONITOR USB CABLE WAS PINCHED. SERVICE REROUTED THE CABLE TO PREVENT POSSIBLE REOCCURRENCE. NO INJURIES TO A USER OR IMPACT TO PATIENT MANAGEMENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349455 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1