BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TETRAPHENYL BORATE, COLORIMETRY, POTASSIUM

    MDR report key: 1847583 · Received September 29, 2010

    Report

    Report Number
    1823260-2010-05766
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    March 24, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEJ
    PMA / PMN Number
    K904033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION OF RESPONSE: IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE POTASSIUM RESULTS AND PROVIDED RESULTS FOR THREE PATIENT SAMPLES. TWO OF THE PATIENTS HAD DISCREPANT POTASSIUM RESULTS. PATIENT 1, INITIAL RESULT WAS 2.31 MMOL/L, THE FIRST REPEAT GAVE 3.69 MMOL/L. THE SAME SAMPLE REPEATED AGAIN AT AN EXTERNAL LABORATORY GAVE 3.69 MMOL/L. PATIENT 2, INITIAL RESULT WAS 3.35 MMOL/L, THE FIRST REPEAT GAVE 4.12 MMOL/L. THE SAME SAMPLE REPEATED AGAIN AT AN EXTERNAL LABORATORY GAVE 4.00 MMOL/L. IT IS UNKNOWN WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER BEGAN USING A NEW LOT OF POTASSIUM STRIPS. THE ANALYZER USED FOR TESTING WAS A REFLOTRON IV INSTRUMENT, (B)(4). CUSTOMER RETURNED STRIPS AND RELEVANT RETENTION MATERIALS WERE TESTED. NO ABNORMALITIES WERE IDENTIFIED. THE DIFFERENCES COULD NOT BE CONFIRMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1