BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYZER

    MDR report key: 2842526 · Received November 21, 2012

    Report

    Report Number
    1823260-2012-05927
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED INDICATING THE UNIT OF MEASURE WAS MMOL/L. THE FOLLOWING PATIENT INFORMATION WAS PROVIDED, HOWEVER NO INFORMATION WAS PROVIDED TO DETERMINE WHICH PATIENT INFORMATION CORRESPONDS TO WHICH SET OF RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM AND POTASSIUM RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. DATA WAS PROVIDED FOR SEVEN PATIENT SAMPLES. THE UNIT OF MEASURE WAS NOT PROVIDED. CLARIFICATION HAS BEEN REQUESTED. PATIENT SAMPLE 1 INITIAL SODIUM RESULT WAS 99 AND THE REPEAT RESULT WAS 145. THE INITIAL POTASSIUM RESULT WAS 3.3 AND THE REPEAT RESULT WAS 4.9. ON (B)(6) 2012, PATIENT SAMPLE 2 INITIAL SODIUM RESULT WAS 119 AND THE REPEAT RESULT WAS 143. ON (B)(6) 2012, PATIENT SAMPLE 3 INITIAL SODIUM RESULT WAS 116 AND THE REPEAT RESULT WAS 139. THE INITIAL POTASSIUM RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.7. ON (B)(6) 2012, PATIENT SAMPLE 4 INITIAL SODIUM RESULT WAS 118 AND THE REPEAT RESULT WAS 142. ON (B)(6) 2012, PATIENT SAMPLE 5 INITIAL SODIUM RESULT WAS 107 AND THE REPEAT RESULT WAS 136. ON (B)(6) 2012, PATIENT SAMPLE 6 INITIAL POTASSIUM RESULT WAS 4.2 AND THE REPEAT RESULT WAS 5.2. ON (B)(6) /2012, PATIENT SAMPLE 7 INITIAL SODIUM RESULT WAS 119 AND THE REPEAT RESULT WAS 132. NO INFORMATION WAS PROVIDED TO DETERMINE IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY OR IF ANY PATIENTS WERE ADVERSELY AFFECTED. THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE SAMPLE PROBE WAS CHECKED AND IT WAS DETERMINED THE SURFACE WAS ROUGH AND "TENDENCY TO HOOK FOUND ON SAMPLE PROBE." THE SAMPLE PROBE WAS EXCHANGED AND NO FURTHER PROBLEMS OCCURRED ACCORDING TO FOLLOW UP WITH THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYZER CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1