BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-G

    MDR report key: 3180557 · Received June 20, 2013

    Report

    Report Number
    3002809144-2013-00138
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT HAVAB IGG, LIST 6C29, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, HAVAB-G, LIST NUMBER 6L27.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF HISTORICAL DATA, A REVIEW OF LABELING AND SPECIFICITY TESTING. THE INVESTIGATION INCLUDED REVIEW OF THE SUBMITTED DATA AND PRODUCT HISTORICAL DATA. REVIEW OF THE DATA DID NOT IDENTIFY ANY PRODUCT ISSUE OR ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE 2 SPECIMENS WERE TESTED WITH A RETAINED KIT OF (B)(6). THE SAMPLE FROM THE OPERATING ROOM WAS TESTED (B)(6). THE SAMPLE FROM THE TRAUMA WARD WAS (B)(6). THEREFORE, THE DISCREPANCY OF RESULTS OBSERVED BETWEEN THE TWO SAMPLES ON BOTH (B)(6) WERE REPRODUCED. TAKING INTO CONSIDERATION THE (B)(6). A RETAINED KIT OF (B)(6), LOT NUMBERS 22604LI00 WAS CALIBRATED AND ALL CALIBRATIONS MET INSTRUMENT SPECIFICATIONS. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. TO EVALUATE REAGENT SPECIFICITY, ADDITIONAL 16 REPLICATES OF (B)(6) CONTROL WERE TESTED. ALL (B)(6) CONTROL VALUES MET SPECIFICATIONS AND THE RESULTS WERE IN THE TYPICAL RANGE AND NO FALSE REACTIVE RESULTS WERE OBTAINED. ALL GENERATED DATA DEMONSTRATE THAT THE PERFORMANCE OF THE (B)(6), LOT NUMBERS 22604LI00, IS NOT COMPROMISED. BASED ON OUR INVESTIGATION, IT WAS DETERMINED THAT THE (B)(6), LOT NUMBER 22604LI00 IS PERFORMING ACCEPTABLY AND NO MALFUNCTION OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A (B)(6) RESULT ON THE ARCHITECT I2000SR ANALYZER. TWO DIFFERENT SAMPLES FROM ONE PATIENT (SID (B)(6), TAKEN IN THE TRAUMA WARD; SID (B)(6) TAKEN IN THE OR) WERE SENT TO THE LAB AND WERE TESTED ON (B)(6) 2013. THE FOLLOWING DATA WAS PROVIDED: (B)(6). CONTROLS WERE IN RANGE. PER THE ARCHITECT HAVAB IGG PACKAGE INSERT SAMPLES WITH S/CO < 1.00 ARE NONREACTIVE FOR (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279547 ARCHITECT HAVAB-G LOL ABBOTT GERMANY 22604LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-02, SN (B)(4)| LN 03M74-02, SN (B)(4)| ARCHITECT I2000SR ANALYZER