BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CARBON DIOXIDE

    MDR report key: 7671710 · Received July 9, 2018

    Report

    Report Number
    1628664-2018-00265
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Report Date
    September 5, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    KHS
    UDI-DI
    00380740005955
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SUSPECT MEDICAL DEVICE. MANUFACTURER FROM: ABBOTT LABORATORIES 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064-3500, USA MAIL TO:(B)(4). FAX: (B)(4). TO: ABBOTT MANUFACTURING INC 1921 HURD DRIVE, IRVING, TX 75038, USA; CORRECTION TO ALL MANUFACTURERS, MANUFACTURING SITE FOR DEVICES: FROM ABBOTT LABORATORIES, 100 ABBOTT PARK ROAD, ABBOTT PARK, IL 60064-3500, USA MAIL TO:(B)(4). FAX: (B)(4). TO: ABBOTT MANUFACTURING INC 1921 HURD DRIVE, IRVING, TX 75038, USA.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE ARCHITECT SERIAL NUMBER (B)(4) INSTRUMENT LOGS WAS PERFORMED. THE SAMPLE IDENTIFICATION DATA AND CO2 RESULTS WERE LOCATED AND THE INITIAL RESULTS WERE GENERATED AROUND 12:54 / FIRST RERUN AT 14:09 / SECOND RERUN AT 14:27 HOURS / AND THE THIRD RERUN AT 15:27. A LARGER DROP IN CO2 RESULTS OCCURRED BETWEEN THE INITIAL TESTING AND THE FOLLOW UP TESTING WHICH WAS APPROXIMATELY 1 HOUR 20 MINUTES BETWEEN MEASUREMENTS. A REVIEW OF TICKETS FOR LOT 51686UQ08 IDENTIFIED ONE OTHER COMPLAINT WHICH WAS ALSO FOR PATIENT RESULTS, HOWEVER, THE INVESTIGATION FOUND NO DEFICIENCY. THERE WERE NO TRENDS IDENTIFIED FOR THIS LOT FOR SIMILAR ISSUES. A REVIEW OF LABELING WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. SAMPLES, ON AVERAGE, MAY LOSE UP TO 6% OF THEIR TOTAL CO2 WITHIN THE FIRST HOUR. ADDITIONAL ENVIRONMENTAL CONDITIONS SUCH AS DRAFTS FROM AIR CONDITIONING OR AIR HANDLING SYSTEMS (FANS, ETC), SAMPLE HANDLING OR STORAGE AFTER THE INITIAL ANALYSIS MAY INCREASE THE SPEED OF SAMPLE CO2 LOSS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CLIN CHEM CO2 REAGENT, LOT 51686UQ08.

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2018-00108 FOR THE INCORRECT MANUFACTURER: ABBOTT LABORATORIES, (B)(4), USA. THIS SUBMISSION CORRECTS THE MANUFACTURER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A. PATIENT INFORMATION, 1. PATIENT IDENTIFIER: MULTIPLE = SID (B)(6). THERE IS NO FURTHER PATIENT INFORMATION OBTAINED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED CO2 RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE FOR 5 SAMPLES: SID (B)(6) = 33.27 / 24.67; SID (B)(6) = 31.89 / 24.26; SID (B)(6) = 31.75 / 23.68; SID (B)(6) = 32.47 / 24.67; SID (B)(6) = 32.87 / 24.52. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512427 CLINICAL CHEMISTRY CARBON DIOXIDE CARBON DIOXIDE KHS ABBOTT MANUFACTURING INC 51686UQ08 00380740005955

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000 ANALYZER, LIST # 02P24-01| ARCHITECT C4000 ANALYZER, LIST # 02P24-01| ARCHITECT C4000 ANALYZER, LIST # 02P24-01| SERIAL # (B)(4). | SERIAL # (B)(4). | SERIAL # (B)(4).