BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3447329 · Received November 4, 2013

    Report

    Report Number
    1628664-2013-00305
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Report Date
    October 9, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A PATIENT WITH FALSELY ELEVATED B12 RESULTS ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) = 150, 142, 175, 256 PG/ML. THE CUSTOMERS REFERENCE RANGE IS 187 TO 883 PG/ML. THIS PATIENT IS KNOWN TO BE B12 DEFICIENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567845 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC
    567846 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LIST 07K61-25, LOT 32901U100| ARCHITECT B12 REAGENT KIT