BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX

    MDR report key: 4535881 · Received February 12, 2015

    Report

    Report Number
    3002807968-2015-00008
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 15, 2015
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA LOGS FROM THIS ANALYZER AND DATA FROM OTHER ANALYZERS AT THE SAME HOSP HAVE BEEN RECEIVED AND ANALYZED. ADDITIONALLY, RADIOMETER HAS VISITED THE CUSTOMER TO INVESTIGATE THE CAUSE OF THIS PROBLEM. IT HAS BEEN IDENTIFIED THAT A CLOT WAS THE CAUSE OF THE HIGH NA RESULT. THESE CLOTS ARE MOST LIKELY CAUSED BY THE STORAGE OF THE SAMPLERS PRIOR TO MEASURING. THE CUSTOMER HAS BEEN ADVISED HOW TO AVOID THIS PROBLEM IN THE FUTURE. PLEASE NOTE THAT SIMILAR INCIDENTS HAVE BEEN REPORTED FROM OTHER ANALYZERS AT THIS HOSP WITH MDR REFERENCE NUMBERS 3002807968-2014-00047, -56, -58, -59, 2015-00006, -07 AND -09.

    Description of Event or Problem · 1

    THE CUSTOMER ROUTINELY PERFORMED A PT CORRELATION PER PROTOCOL (COMPARED THE RESULTS TO FIVE OTHER ANALYZERS) TO MAKE SURE THE ANALYZER WAS INDEED READY. THE MEASUREMENT FAILED, READING NA+ 6 MMOL/L HIGHER THAN THE OTHER ANALYZERS BUT NO ERROR CODES WERE SHOWN. THE RESULT FROM THE ABL90 WITH SN: (B)(4) WAS NOT USED AND THERE WAS THUS NO REPORTED INJURY, DIAGNOSIS OR TREATMENT BASED ON THE HIGH SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103389 ABL90 FLEX BLOOD GAS ANALYZER CHL RADIOMETER MEDICAL APS ABL90 FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1