BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX ANALYZER

    MDR report key: 7905283 · Received September 25, 2018

    Report

    Report Number
    3002807968-2018-00057
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 5, 2018
    Report Date
    February 27, 2019
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    JGS
    UDI-DI
    05700693930909
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION NOTHING INDICATED ANYTHING WRONG WITH THE AFFECTED ABL90 ANALYZER. THE DIFFERENCE BETWEEN THE TWO ANALYZERS (ABL90 AND ABBOTT) CAN BE EXPLAINED WITH TWO CONTRIBUTIONS: A POSITIVE BIAS FROM THE ABL90 FLEX ANALYZER, RADIOMETER ARE AWARE THAT THE ABL90 HAS A POSITIVE BIAS ABOUT 4-5 MM FOR HIGH NA+LEVELS (> 150 MM) MEASURED AGAINST THE NIST STANDARDS. A DIFFERENCE BETWEEN ANALYZERS.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT RECEIVED, USERS FROM THE NICU AND PICU REPORTED THAT NA+ RESULTS FROM THE ABL90 FLEX ANALYZER DEMONSTRATED AN UNACCEPTABLE DISCREPANCY COMPARED TO RESULTS FROM AN ABBOTT ARCHITECT C16000 USED IN LABORATORY. THIS DISCREPANCY IS MAINLY SEEN FOR RESULTS AT HIGH LEVELS ABOVE 150 MMOL/L). THE FOLLOWING PATIENT MEASUREMENTS WERE OBTAINED: PATIENT 1 - (B)(6) 2018 20:42: 165 MMOL/L (RADIOMETER ABL90 FLEX), 156 MMOL/L (ABBOTT ARCHITECT C16000), 9 MMOL/L (DISCREPANCY). PATIENT 2 - (B)(6) 2018 23:55: 164 MMOL/L(RADIOMETER ABL90 FLEX), 155 MMOL/L (ABBOTT ARCHITECT C16000), 9 MMOL/L (DISCREPANCY). PATIENT 1- (B)(6) 2018: 157 MMOL/L (RADIOMETER ABL90 FLEX), 150 MMOL/L (ABBOTT ARCHITECT C16000), 7 MMOL/L (DISCREPANCY). PATIENT 2 - (B)(6) 2018: 151 MMOL/L (RADIOMETER ABL90 FLEX), 142 MMOL/L (ABBOTT ARCHITECT C16000), 8 MMOL/L (DISCREPANCY). BEFORE THE PATIENT SAMPLE MEASUREMENTS, ALL CALIBRATIONS AND QCS OF THE ABL90 FLEX WERE PASSED. PATIENT 1 HAD URINARY FREQUENCY AND IS ON DDAVP MEDICATION (SUBLINGUAL). THIS PATIENT STAYED AT THE HOSPITAL MORE THAN A WEEK. BASED ON THE OBTAINED MEASUREMENTS, THE CUSTOMER REPORTED THE RESULTS FROM THE ABL90 FLEX ANALYZER AS FALSE HIGH NA+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748724 ABL90 FLEX ANALYZER ABL90 FLEX ANALYZER JGS RADIOMETER MEDICAL APS 393-090 05700693930909

    Patients

    Seq Age Sex Outcome Treatment
    1