BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02003

    MDR report key: 6868799 · Received September 15, 2017

    Report

    Report Number
    1823260-2017-02003
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 25, 2017
    Report Date
    October 9, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER ADJUSTED THE ULTRASONIC MIXERS OF THE ANALYZER AND CONFIRMED THE ANALYZER WAS BACK WITHIN SPECIFICATIONS. THE OBSERVED RESULT OUTLIERS STRONGLY INDICATES AN ISSUE WITH A MISADJUSTED MIXER. REAGENT ISSUES CAN BE EXCLUDED AS PRECISION WAS FINE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR DIG DIGOXIN (DIG) ON A COBAS 6000 C (501) MODULE - C501. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 1.17 NG/ML. THE SAMPLE WAS REPEATED, RESULTING AS 0.97 NG/ML. THE SAMPLE WAS REPEATED THREE MORE TIMES ON (B)(6) 2017, RESULTING AS 1.44 NG/ML, 1.25 NG/ML, AND 1.03 NG/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. IT WAS RECOMMENDED TO THE CUSTOMER TO COLLECT ANOTHER SAMPLE FROM THE PATIENT. THE DIG REAGENT LOT NUMBER WAS 227984. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE CUSTOMER PERFORMED PRECISION STUDIES WITH ANOTHER PATIENT SAMPLE. QUALITY CONTROL RECOVERY WAS STATED TO BE "NOT SO GOOD".

    Patients

    Seq Age Sex Outcome Treatment
    1