BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 2630777 · Received June 21, 2012

    Report

    Report Number
    1217157-2012-00025
    Event Type
    Other
    Date Received
    June 21, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS TRIED TO REPRODUCE THE PROBLEM BY RUNNING QC IN SAMPLE MODE AND CANNOT GET IT TO DO IT AGAIN. ORIGINALLY MANUFACTURER SUSPECTED CONTAMINATION WITH CLEANING COMPOUND CONTAINING BENZLKONIUM BUT CUSTOMER HAVE CONFIRMED THAT THEY ARE USING A NEW SAMPLE PORT AND NOT WASHING OR CLEANING IT. MANUFACTURING HYPOTHESIS IS THAT RESULT WOULD BE CONSISTENT WITH A SALT CRYSTAL POTENTIALLY CONTAMINATED THE SAMPLE BECAUSE EITHER THE SAMPLE PORT WAS NOT REPLACED CORRECTLY OR CUSTOMER INTRODUCED A SMALL SALT CRYSTAL WHEN THEY REPLACED THE PORT. HOWEVER THIS IS IMPOSSIBLE TO PROVE. NOTHING ABNORMAL WAS SEEN ON THE SENSOR RESPONSE CURVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO SYRINGE SAMPLES HAD BEEN RUN ON THE RP405 AND PRODUCED INCORRECT RESULTS. NO REPORT OF PATIENT INJURY. THE FIRST SAMPLE WAS A SYRINGE TAKEN FROM A BABY (THIS WAS NOT A BLOOD GAS SYRINGE). SOME OF THE BLOOD WAS TRANSFERRED INTO A CAPILLARY AND ANALYZED ON THE INSTRUMENT. THE SODIUM WAS HIGH (159 MMOL/L) AND GLUCOSE WAS LOW (2.8 MMOL/L). SUBSEQUENTLY, THE BABY WAS TREATED FOR THE LOW GLUCOSE. THE SECOND SAMPLE WAS TAKEN IN A BLOOD GAS SYRINGE AND ANALYZED DIRECTLY ON THE INSTRUMENT. THIS WAS FROM A (B)(6) FEMALE. THERE WAS APPARENTLY A D39 ERROR WITH INITIAL SAMPLING AND THE OPERATOR WAS INSTRUCTED TO REPLACE THE SAMPLE PORT. THE OPERATOR HAD TROUBLE PUTTING ON THE NEW SAMPLE PORT AND IT IS ALLEGED IT WASN'T INSTALLED CORRECTLY PRIOR TO SAMPLING. THE RESULT GENERATED WAS A SODIUM OF 191 MMOL/L (OTHER RESULTS ARE UNKNOWN). THE OPERATOR DID NOT BELIEVE THIS RESULT, REPEATED AND 2ND RESULT OF SODIUM 140 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD. 405

    Patients

    Seq Age Sex Outcome Treatment
    1