BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-00571

    MDR report key: 6409010 · Received March 16, 2017

    Report

    Report Number
    1823260-2017-00571
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 16, 2017
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RUN THE NA+ ELECTRODE (SODIUM) ON TWO COBAS INTEGRA 400. ONE OF THE TWO ANALYZERS, A COBAS INTEGRA 400 PLUS (I400+) SYSTEM HAD BAD PERFORMANCE FOR SODIUM. THE CUSTOMER STATED THAT THEY NEEDED TO CALIBRATE AND REPEAT THE CONTROLS MANY TIMES TO GET THEM WITHIN LIMITS. VALUES WERE TOO LOW ON THE I400+. AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE TESTED ON BOTH SYSTEMS AND SHOWED A DIFFERENCE IN RESULTS. THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 7 PATIENT SAMPLES THAT HAD RESULTS THAT WERE QUESTIONED. OF THE 7 SAMPLES, 4 HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND EMERGENCY STATION STAFF COMPLAINED ABOUT THE RESULTS. ALL SAMPLES WERE REPEATED ON THE OTHER INTEGRA 400 ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED AS 130.7 MMOL/L AND WHEN REPEATED ON THE OTHER INTEGRA 400 ANALYZER, IT RESULTED AS 139 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED AS 128.2 MMOL/L AND WHEN REPEATED ON THE OTHER INTEGRA 400 ANALYZER, IT RESULTED AS 133.4 MMOL/L. THE THIRD SAMPLE INITIALLY RESULTED AS 133.0 MMOL/L AND WHEN REPEATED ON THE OTHER INTEGRA 400 ANALYZER, IT RESULTED AS 142 MMOL/L. THE FOURTH SAMPLE INITIALLY RESULTED AS 123 MMOL/L AND WHEN REPEATED ON THE OTHER INTEGRA 400 ANALYZER, IT RESULTED AS 138.2 MMOL/L. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE LOT NUMBER AND EXPIRATION DATE OF THE SODIUM ELECTRODE WERE ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER PERFORMED MAINTENANCE ON THE ANALYZER. IN HIS OPINION, ONLY A COMPLETE EXCHANGE OF THE ISE UNIT WOULD RESOLVE THE ISSUE. IT WAS STATED ON 03/06/2017 THAT NO FURTHER INFORMATION COULD BE PROVIDED BY THE CUSTOMER SINCE THE SYSTEM WAS GOING TO BE DE-INSTALLED A WEEK LATER. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1