BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3585014 · Received January 21, 2014

    Report

    Report Number
    1628664-2014-00007
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Report Date
    December 29, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TEXT INDICATES THAT THE ARCHITECT C8000 HANDHELD BARCODE SCANNER INCORRECTLY SCANNED SAMPLE IDENTIFICATION (SID) (B)(4) AS SID (B)(4). THE CUSTOMER IS USING CODE 39 SYMBOLOGY WITH CHECKSUM DISABLED. AN ABBOTT FIELD REPRESENTATIVE DETERMINED THE MOST LIKELY CAUSE AS: CABLE, MOUSE AND KEYED EXTENSION, 6 FT (PART NUMBER 7-100151-01) AND THE ARCHITECT C8000 (PART NUMBER 01G06-11). FIELD SERVICE REPLACED THE CABLE, MOUSE AND KEYED EXTENSION, 6 FT BECAUSE THE PART WAS WORN OUT FROM NORMAL USE. SUBSEQUENT SERVICE HISTORY DOES NOT INCLUDE FURTHER REPORTS FOR THE WRONG SID BEING SCANNED. THE SYSTEM LOG REVIEW FOUND VARIOUS TEST RESULTS FOR SID (B)(4) WERE GENERATED ON (B)(6) 2013. SAMPLE IDENTIFICATION (B)(4) COULD NOT BE LOCATED. NO ERROR CODES ASSOCIATED WITH THE WRONG SID BEING SCANNED FOR A SAMPLE WERE GENERATED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE CUSTOMER ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT C8000 HANDHELD BARCODE SCANNER MISREAD A SAMPLE. THE SAMPLE ID WAS (B)(6), BUT WAS SCANNED AS (B)(6). THE SAMPLE WAS TAKEN TO SECONDARY INSTRUMENT AND WAS SCANNED CORRECTLY. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48250 ARCHITECT C8000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1