BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2016-00211

    MDR report key: 5880523 · Received August 16, 2016

    Report

    Report Number
    1628664-2016-00211
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Report Date
    May 8, 2017
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHENT THE EVALUATION IS COMPLETE. THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3005094123-2016-00039 UNDER A DIFFERENT SUSPECT DEVICE.

    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.

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE ACCOUNT AND PERFORMED TROUBLE SHOOTING OF THE ANALYZER. VACUUM PUMP (ROHS) PART 7-77795-02 AND VACUUM VALVE PART 7-76446-01 WERE REPLACED AND VACUUM VESSEL REBUILD KIT PART 7-77712-03 WAS REBUILT. REPLACEMENT OF THE VACUUM PUMP WAS CONSIDERED TO BE THE LIKELY CAUSE OF THE CUSTOMER ISSUE AND ARCHITECT I2000SR SERIAL NUMBER (B)(4) WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, REVIEW OF INSTRUMENT SERVICE, AND A REVIEW OF LABELING. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. REVIEW OF THE SERVICE HISTORY FOR ARCHITECT I2000SR SERIAL NUMBER (B)(4) DID NOT SHOW ANY OTHER DISCREPANT RESULTS ISSUES AFTER REPAIRS WERE COMPLETED. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE ANALYZER PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (B-HCG) RESULTS WHILE USING THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MIU/ML): SID (B)(6) INITIAL 34.55 (POSITIVE), REPEAT 10.07 (NEITHER POSITIVE OR NEGATIVE), 24.49 (NEITHER POSITIVE OR NEGATIVE), 3.94 (NEGATIVE), <1.2 (NEGATIVE), <1.2 (NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1