BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2441110 · Received February 7, 2012

    Report

    Report Number
    1628664-2012-00043
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 6, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4): FALSE POSITIVE RESULT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED A PRECISION STUDY ON BOTH ARCHITECT ANALYZERS IN THE LAB AND BOTH GENERATED ACCEPTABLE RESULTS. THE CUSTOMER INDICATED THAT BOTH ANALYZERS ARE PERFORMING AS EXPECTED. THE EVALUATION REVIEWED ALL DATA RETURNED BY THE CUSTOMER AND VERIFIED THE FALSE POSITIVE STAT TROPONIN-I RESULT; HOWEVER, THIS INFORMATION DID NOT IDENTIFY THE CAUSE OF THE FALSELY ELEVATED RESULT. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-108) JANUARY, 2010 AND THE ARCHITECT TROPONIN ASSAY PACKAGE INSERT (840637/R08) CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION, A SINGLE DEFINITIVE CAUSE OF THE CURRENT CUSTOMER ISSUE WAS NOT ABLE TO BE DETERMINED. HOWEVER, SAMPLE PREPARATION AND/OR INADEQUATE SAMPLE VOLUME ARE NOT TO BE RULED OUT AS POTENTIAL CAUSES OF THE CUSTOMER ISSUE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A FALSE POSITIVE ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 0.34 NG/ML WAS GENERATED ON AN ARCHITECT I2000SR ANALYZER (SN (B)(4)) AND REPORTED FROM THE LAB. THIS LAB USES A CUT-OFF VALUE OF 0.30 NG/ML. THE SAMPLE WAS RETESTED ON ANOTHER ARCHITECT I2000SR ANALYZER (SN (B)(4)) AND GENERATED A NEGATIVE RESULT OF 0.09 NG/ML. THE SAMPLE WAS THEN RETESTED ON THE INITIAL ANALYZER AND GENERATED A RESULT OF 0.013 NG/ML. THIS CORRECTED RESULT WAS REPORTED FROM THE LAB WITHIN AN HOUR OF THE INITIAL REPORTED RESULT. THE CUSTOMER OBSERVED THAT THE PLASMA SAMPLE WAS GROSSLY HEMOLYZED AND WAS POURED OFF INTO A MICRO-SAMPLE CUP FOR ANALYSIS. A REPEAT EKG WAS ALSO PERFORMED ON THE PATIENT WITH NO CHANGE FROM THE INITIAL (NO FURTHER INFORMATION PROVIDED). THERE WAS NO FURTHER IMPACT TO THE PATIENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN: 03M74-01 SN: (B)(4)| ARCH STAT TROP-I LN:02K41 LOT: 03031UN11| ARCH STAT TROPONIN-I LN: 02K41 LOT: UNK