BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABL80 FLEX ANALYZER

    MDR report key: 1549480 · Received December 1, 2009

    Report

    Report Number
    2027541-2009-00017
    Event Type
    Injury
    Date Received
    December 1, 2009
    Date of Event
    November 1, 2009
    Report Date
    November 2, 2009
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K051804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS WERE MADE FOR ADDITIONAL DETAILS ABOUT THE INCIDENT. IT IS UNK IF FURTHER MEDICAL INTERVENTION WAS REQUIRED. ONE RESPONSE INDICATED THAT THE CLINICAL PICTURE DID NOT MEASURE UP WITH A POTASSIUM VALUE OF 8.0 MMOL/L. DEVICE LABELING (LIMITATIONS OF USE IN THE OPERATOR'S MANUAL) STATES THAT THE VALIDITY OF THE TEST RESULTS FROM THIS INSTRUMENT MUST BE CAREFULLY EXAMINED BY A CLINICIAN AND RELATED TO THE PT'S CLINICAL CONDITION, BEFORE ANY CLINICAL DECISION IS TAKEN ON THE BASIS OF THE TEST RESULTS. IT IS POSSIBLE THAT SAMPLE HANDLING LEAD TO THE ELEVATED VALUE OF 8.0 MMOL/L. A SMALL BUBBLE LODGED DIRECTLY OVER A SENSOR COULD HAVE CAUSED THE REPORTED EXPERIENCE. THE REFERENCE RANGE FOR POTASSIUM FOR ADULTS' ARTERIAL BLOOD IS 3.4 - 4.5 MMOL/L. DATA LOGS FROM THE ANALYZER IN QUESTION WERE REVIEWED. THE ANALYZER APPEARS TO HAVE BEEN FUNCTIONING WELL AND WITHIN SPECIFICATIONS AT THE TIME OF THE INCIDENT.

    Description of Event or Problem · 1

    IN 2009, A DISTRIBUTOR REPORTED A PROBLEM WHERE THE ABL80 FLEX ANALYZER MEASURED A POTASSIUM VALUE OF 8.0 MMOL/L. BASED ON THIS RESULT, THE PT WAS TREATED WITH RESONIUM AND I.V. SOLUTION WITH 5% GLUCOSE + 20IE ACT. AFTER ABOUT TEN (10) MINUTES, ANOTHER SAMPLE WAS DRAWN AND MEASURED BOTH ON THE ABL80 AND ON A ABL700. THE POTASSIUM RESULT WAS 3.2 MMOL/L. THE TREATMENT WAS STOPPED IMMEDIATELY, BUT THE PT HAD RECEIVED ABOUT 300 ML OF THE FLUID. THE INCIDENT WAS REPORTED TO THE HOSPITAL RISK MGR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL80 FLEX ANALYZER PH, BLOODGAS, ELECTROLYTE ANALYSIS SYSTEM CHL SENDX MEDICAL, INC. 393-839

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention