BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDLAB 1260 BLOOD GAS SYSTEM

    MDR report key: 1052214 · Received May 21, 2008

    Report

    Report Number
    1217157-2008-00005
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 20, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED). RESULTS: THE ANALYZER SENSOR PRODUCED INTERMITTENT ERRONEOUS PH RESULTS. CONCLUSIONS: THE RAPIDLAB 1260 ANALYZER PRODUCED INTERMITTENT ERRONEOUS PH RESULTS ON TWO DIFFERENT DATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RAPIDLAB 1260 ANALYZER PRODUCED INTERMITTENT ERRONEOUS PH RESULTS. CUSTOMER REPORTS AN EVENT OCCURRED IN 2008, BUT NO COMPLIANT WAS SUBMITTED. AT THAT TIME, A FIELD SERVICE ENGINEER CHECKED CALIBRATION AND QUALITY CONTROL AND NO OUTLIERS WERE IDENTIFIED. THE FOLLOWING MONTH, A SAMPLE WAS MEASURED ON THE ANALYZER PRODUCING A PH RESULT OF 6.913. THE PHYSICIAN ASKED THE LAB FOR CONFIRMATION OF THE PH RESULT. THE SAMPLE WAS RETESTED ON THE ANALYZER AND PRODUCED A PH RESULT OF 7.338. THE SYRINGE (SAMPLE) WAS RETESTED ON TWO OTHER ANALYZERS AND PRODUCE PH RESULTS OF 7.329 AND 7.337.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB 1260 BLOOD GAS SYSTEM RAPIDLAB 1260 CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. RL1260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK