BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL80 FLEX ANALYZER

    MDR report key: 2577531 · Received May 11, 2012

    Report

    Report Number
    2027541-2012-00031
    Event Type
    Other
    Date Received
    May 11, 2012
    Date of Event
    February 29, 2012
    Report Date
    April 12, 2012
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K051804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA LOGS FROM THE SUBJECT ANALYZER WERE REVIEWED. CALIBRATION AND QUALITY CONTROL RECORDS DEMONSTRATE A PROPERLY FUNCTIONING ANALYZER WITHIN MANUFACTURING SPECIFICATIONS. THE USER PROVIDED COMPARISON DATA COLLECTED AFTER THE EXPERIENCE DOCUMENTED HERE WHICH DEMONSTRATED A MARGINALLY LOW PO2 BIAS WITH SOME RESULTS. THE SENSOR CASSETTE AND SOLUTION PACK USED ON THE ANALYZER DURING THE SUBJECT SAMPLE MEASUREMENT HAVE BEEN REQUESTED FOR RETURN. A FAILURE INVESTIGATION WILL BE PREFORMED UPON RECEIPT OF THESE CONSUMABLE ITEMS.

    Description of Event or Problem · 1

    ON 04/12/2012 A CLINICIAN REPORTED THAT A PATIENT HAD A CHEST SCAN WITH CONTRAST MEDIA BASED ON THE PO2 RESULTS FROM AN ABL80 FLEX ANALYZER WITH BASIC SOFTWARE THAT WAS LATER CONSIDERED TO BE LOW COMPARED TO THE SATURATION RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR