BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3802827 · Received May 9, 2014

    Report

    Report Number
    1628664-2014-00096
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. NO ABNORMALITIES WERE INDICATED IN THIS UNIT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. AN ABBOTT FIELD SERVICE REPRESENTATIVE REPLACED THE FOLLOWING PARTS: WASH ZONE 2 VALVE DRAIN VACUUM VESSEL (PART NUMBER 7-76447-01) BECAUSE THE VALVE WAS BLOCKED/CORRODED. FIELD SERVICE CONSIDERED THIS PART THE CAUSE OF ERROR CODE 3700. STAT AND R2 SYRINGE (PART NUMBER 7-779650-02) DUE TO LEAKING. VACUUM PUMP DIAPHRAGMS (7-201782-01) DUE TO WORN OUT FROM NORMAL USE. A SINGLE DEFINITIVE CAUSE WAS NOT IDENTIFIED. AN ISSUE WITH SAMPLE INTEGRITY COULD NOT BE RULED OUT; AS THE ISSUE WAS ISOLATED TO A SINGLE SAMPLE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSE POSITIVE TROPONIN RESULT FOR ONE PATIENT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 38.5 NG/L, REPEAT 3.1 NG/L, 0.1 NG/L, 8.1 NG/L. ON ANOTHER ANALYZER IN LAB RESULT WAS 6.3 NG/L AND 5.4 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280342 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 02K41-38 LOT 89576UN13| LN 02K41-38 LOT 89576UN13| ARCHITECT TROPONIN-I REAGENTS| ARCHITECT TROPONIN-I REAGENTS