BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 9393449 · Received December 2, 2019

    Report

    Report Number
    3002807968-2019-00057
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 13, 2019
    Report Date
    April 23, 2020
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER USED A NON-RADIOMETER BLOOD SAMPLER, BUT SINCE 1-JAN-2020 RADIOMETER'S PICO70 SAMPLER WAS USED INSTEAD. COINCIDENTALLY, NO MORE SPURIOUS NA & CA RESULTS WAS REPORTED. MOST LIKELY, THE ISSUE AT THE CUSTOMER WAS USE OF A NON-RADIOMETER BLOOD SAMPLER BUT THIS CAN'T BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT RELATES TO TWO OTHER INCIDENTS, REPORTED AS 3002807968-2019-00056 AND 3002807968-2019-00058.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, CUSTOMER SAMPLES FROM A PATIENT WERE MEASURED ON AN ABL800 FLEX ANALYZER WITH THE FOLLOWING RESULTS FOR NA+ AND CA2+: (B)(6) 2019 / 20:16 (MEASUREMENT TIME) / NA+: TECH ERROR (MEASUREMENT UNSTABLE) / CA2+: 1.51 MMOL/L. (B)(6) 2019 / 23:33 (MEASUREMENT TIME) / NA+: 148 MMOL/L / CA2+: 1.47 MMOL/L. LAB RESULTS FOR COMPARISON: (B)(6) 2019/ 20:20 (MEASUREMENT TIME) / NA+: 138 MMOL/L. BASED ON THE SERIES OF MEASUREMENTS, THE CUSTOMER REPORTS THE RESULTS FOR NA+ AS FALSE HIGH. NO LAB RESULTS FOR CA2+ WAS AVAILABLE, BUT THE CUSTOMER STILL REPORTS THE RESULTS AS FALSE HIGH. THE CUSTOMER HAS REPLACED THE REFERENCE MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188489 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1