BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2760572 · Received September 26, 2012

    Report

    Report Number
    1628664-2012-00438
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, REVIEW OF THE INSTRUMENT LOG, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. FROM THE TROUBLESHOOTING QUESTIONS, WE CONFIRMED IN THE INSTRUMENT LOG THAT IT WAS DECONTAMINATED WITH A BLEACH SOLUTION ON (B)(6) 2012, ONE DAY BEFORE THE EVENTS OCCURRED. WE INFORMED THE CUSTOMER THAT FALSE HIGH RESULTS COULD HAVE OCCURRED DUE TO THE FACT THAT THERE WAS SOME RESIDUE FROM THE DECONTAMINATION THAT COULD HAVE INTERFERED IN THE ASSAY. THE ISSUE WAS ADDRESSED BY REPLACING WASH ZONE MANIFOLD VALVES AND DECONTAMINATING THE SYSTEM. THE DECONTAMINATION WAS IDENTIFIED AS THE PRECURSOR TO THE ISSUE DESCRIBED IN THE CURRENT COMPLAINT. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. 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

    (B)(4). 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 OBSERVED A FALSELY ELEVATED INSULIN RESULT WHILE USING THE ARCHITECT I2000SR ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING DATA: (B)(6) 2012: INITIAL 71.4UU/ML, THE RESULT WAS QUESTIONED BY THE PHYSICIAN AND RERUN ON (B)(6) 2012: 23.6 UU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS DOCUMENTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1