BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL80 FLEX ANALYZER

    MDR report key: 2685394 · Received July 31, 2012

    Report

    Report Number
    2027541-2012-00036
    Event Type
    Other
    Date Received
    July 31, 2012
    Report Date
    July 4, 2012
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K051804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEFICIENCY EXPRESSED BY THE CUSTOMER RESEMBLES THAT OF A PREVIOUSLY REPORTED MDR, THIS EVENT WILL BE REPORTED AS AN MDR ACCORDING TO THE 2-YEAR ASSUMPTION RULE EVEN THOUGH NO EVIDENCE OF A MALFUNCTION COULD BE ESTABLISHED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED PO2 RESULTS FROM AN ABL80 FLEX ANALYZER THAT WERE UP TO 20 MMHG LOWER THAN EXPECTED BY PHYSICIAN. THE SAMPLES WERE FROM ADULT PTS AND COLLECTED IN CAPILLARY TUBES. THE REPORTED RESULTS WERE NOT USED FOR ANY PT DIAGNOSIS OR TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1