BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX PLUS ANALYZER

    MDR report key: 17727224 · Received September 12, 2023

    Report

    Report Number
    3002807968-2023-00045
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 30, 2023
    Report Date
    November 8, 2023
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930923
    PMA / PMN Number
    K160153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOMETER INVESTIGATIONS WERE UNABLE TO ESTABLISH THE PRECISE MEASUREMENT ERROR AND IF SPECIFICATIONS ARE MEET, AS THE TRUE VALUE OF THE PATIENT SAMPLE IS UNKNOWN. NO PRODUCTS WERE NOT RETURNED. HENCE, IT WAS CONCLUDED THAT THE ROOT CAUSE OF THIS INCIDENT IS UNKNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, ON (B)(6) 2023 SAMPLES WERE MEASURED, AND THE FOLLOWING RESULTS WERE OBTAINED: MEASURED ON 2023-08-30, 06:30 ON ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6)). 1) CK: 4.0MMOL/L. 2) NA: 138MMOL/L. 3) CA: 1.15 MMOL/L. MEASURED ON 2023-08-30, 06:30 ON ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6)): 1) CK: 3.7MMOL/L (CONSIDERED DISCREPANT). 2) NA: 130MMOL/L (CONSIDERED DISCREPANT). 3) CA: 0.98MMOL/L (CONSIDERED DISCREPANT). MEASURED ON 2023-08-30, 08:00 IN THE LAB: 1) CK: 4.4MMOL/L . 2) NA: 138MMOL/L. 3) CA: 1.99MMOL/L. MEASURED ON 2023-08-30, 21:32 ON ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6)). 1) CK: 4.2MMOL/L. 2) NA: 139MMOL/L. 3) CA: 1.18 MMOL/L. MEASURED ON 2023-08-30, 21:32 ON ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6)): 1) CK: 4.0MMOL/L (CONSIDERED DISCREPANT). 2) NA: 131MMOL/L (CONSIDERED DISCREPANT). 3) CA: 1.04MMOL/L (CONSIDERED DISCREPANT). BASED ON THESE MEASUREMENTS, THE CUSTOMER HAS REPORTED THE CK, NA AND CA MEASUREMENTS FROM THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6)) AS FALSE LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174132 ABL90 FLEX PLUS ANALYZER ABL90 FLEX PLUS ANALYZER CHL RADIOMETER MEDICAL APS 393-092 05700693930923

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female