BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 SR ANALYZER

    MDR report key: 2110706 · Received June 1, 2011

    Report

    Report Number
    1628664-2011-00249
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO RESULTS OF INVESTIGATION BELOW. AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, INSTRUMENT SERVICE HISTORY, AND OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES. THE CUSTOMER'S ISSUE WAS RESOLVED BY REPLACING THE STAT PIPETTOR PROBE AND PERFORMING THE SAMPLE PIPETTOR CALIBRATION. TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, ERRATIC ASSAY RESULTS IN THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS MULTIPLE PROBABLE CAUSES FOR ERRATIC RESULTS, INCLUDING PROBE TIP BENT OR DAMAGED AND THE PROBE NOT POSITIONED CORRECTLY. CORRECTIVE ACTIONS INCLUDE REPLACING THE PROBE AND PERFORMING PIPETTOR CALIBRATION. A REVIEW OF THE SERVICE HISTORY FOR ARCHITECT SERIAL # (B)(4) DID NOT IDENTIFY ISSUES RELATED TO THIS COMPLAINT. A REVIEW OF CUSTOMER COMPLAINTS AND QUALITY METRICS DID NOT IDENTIFY AN ADVERSE TREND RELATED TO THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION, THE LIKELY CAUSE OF THE ISSUE WAS A DAMAGED STAT PROBE OR POOR PROBE ALIGNMENT AND WAS RESOLVED BY REPLACING THE PROBE AND CALIBRATING THE PIPETTOR. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT ANALYZER GENERATED AN INITIAL TROPONIN RESULT OF 0.033 NG/ML (B)(6). THE SAMPLE WAS REPEATED WITH A RESULT OF 0.010 NG/ML (NEGATIVE). THE ACCOUNT WAS USING A CUTOFF OF 0.03 NG/ML AS (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # 60180UN10| ARCHITECT TROPONIN LN 2K41-20 LOT 60180UN10| ARCHITECT STAT TROPONIN-I LIST # 2K41-20