BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2386933 · Received December 22, 2011

    Report

    Report Number
    1628664-2011-00749
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    December 8, 2011
    Report Date
    December 14, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    NIG
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT I2000SR ANALYZER, LIST 03M74-01, (B)(4) MANUFACTURING SITE TO ARCHITECT CA 19-9XR ASSAY, LIST 02K91-25, (B)(4) MANUFACTURING SITE. MDR NUMBERS 1415939-2012-00055 AND 1415939-2012-00056 HAVE BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THOSE MDR NUMBERS.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. PATIENT PROBLEM CODE: NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT (B)(4). DEVICE PROBLEM CODE: INCORRECT OR INADEQUATE RESULT (B)(4). COMPLETE PATIENT IDENTIFICATION NUMBER: (B)(4). ARCH I2000SR LN: (B)(4), SN: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED THE FOLLOWING RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ARCHITECT CA 19-9XR ASSAY: INITIAL RESULT OF >1200 U/ML (NEAT; REAGENT LOT (B)(4)) ON ARCHITECT I2000SR SN: (B)(4), RETESTED AT 905.76 U/ML (1:2; REAGENT LOT (B)(4)) ON ARCHITECT I2000SR SN: (B)(4). THE FOLLOWING RESULTS WERE ALL GENERATED WITH REAGENT LOT (B)(4) ON ARCHITECT I2000SR SN: (B)(4): 677.79 U/ML (1:10); >1200 U/ML (NEAT); 702.84 U/ML ; 495.55 U/ML (1:5); 596.74 U/ML (1:10). THE FOLLOWING DAY THE SAMPLE WAS RETESTED AGAIN: >1200 U/ML (NEAT); AND, 603.93 U/ML (1:10). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHCA 19-9XR LN: (B)(4) LOT: (B)(4)| ARCHCA 19-9XR LN: (B)(4) LOT:01083M500| ARCHCA 19-9XR LN: (B)(4) LOT: (B)(4)| ARCHCA 19-9XR LN: (B)(4) LOT:02949M500| ARCH I2000SR LN: (B)(4) SN: (B)(4)