BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON POTASSIUM TEST TABS

    MDR report key: 1840628 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05613
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 16, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEJ
    PMA / PMN Number
    K904033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED STRIPS FOR INVESTIGATION. INVESTIGATION OF THE RETURNED CUSTOMER STRIPS AND RETENTION MATERIALS DETERMINED THE STRIPS PERFORMED AS SPECIFIED. THE DIFFERENCES COULD NOT BE CONFIRMED. NO MALFUNCTION WAS DETECTED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE POTASSIUM RESULTS WHEN COMPARING TWO DIFFERENT POTASSIUM STRIP LOT NUMBERS. THE INSTRUMENT USED FOR TESTING WAS A REFLOTRON IV, (B)(4). THE ORIGINAL POTASSIUM STRIP LOT NUMBER ALLEGED TO PRODUCE QUESTIONABLE RESULTS WAS 23761332. THE NEW POTASSIUM STRIP LOT NUMBER WAS 23761534. THE CUSTOMER PROVIDED COMPARISON RESULTS FOR SIX PATIENT SAMPLES, ONE EXTERNAL CONTROL, AND ONE INTERNAL CONTROL (RUN AS A RANDOM SAMPLE). RESULTS FROM ONE PATIENT AND THE INTERNAL CONTROL WERE DISCREPANT: THE PATIENT SAMPLE ORIGINAL POTASSIUM RESULT USING STRIP LOT NUMBER 23761332 WAS 2.41 MMOL/L. THE SAMPLE, REPEATED WITH STRIP LOT NUMBER 23761534, GAVE 4.75 MMOL/L. THE INTERNAL CONTROL ORIGINAL POTASSIUM RESULT USING STRIP LOT NUMBER 23761332 WAS 2.36 MMOL/L. THE CONTROL, REPEATED TWICE WITH STRIP LOT NUMBER 23761534, GAVE 4.32 MMOL/L BOTH TIMES. ALL DETERMINATIONS WERE PERFORMED IN THE DOCTOR'S OFFICE. IT IS UNKNOWN WHICH RESULTS WERE REPORTED TO A PHYSICIAN. NO INFORMATION ABOUT FURTHER ACTIONS TAKEN BY THE PHYSICIAN WERE AVAILABLE. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR #16. THE SITE RESTARTED THE SYSTEM AND ENCOUNTERED SYSTEM ERROR #31030 ON START UP. TO ATTEMPT TO TROUBLESHOOT THE ISSUE, THE SITE POWERED DOWN THE SYSTEM, EMERGENCY POWERED OFF (EPO'S) THE PT SIDE CART (PSC) AND RESET THE BREAKER ON ALL THE COMPONENTS. THE ENDS OF THE SYSTEM CABLES WERE SWAPPED BETWEEN THE CONSOLE AND PSC; HOWEVER, SYSTEM ERROR #31030 REOCCURRED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLOTRON POTASSIUM TEST TABS TETRAPHENYL BORATE, COLORIMETRY, POTASSIUM CEJ ROCHE DIAGNOSTICS 23761332

    Patients

    Seq Age Sex Outcome Treatment
    1