BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01819

    MDR report key: 6820022 · Received August 25, 2017

    Report

    Report Number
    1823260-2017-01819
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    May 17, 2017
    Report Date
    September 28, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CONTAMINATED SAMPLE PROBE WAS REPLACED AND NO FURTHER ISSUE WAS REPORTED. A TYPICAL ROOT CAUSE OF PROBE CONTAMINATION IS IMPROPER PREANALYTICS. INSOLUBLE MATERIAL IN THE SAMPLE SUCH AS FIBRIN, GEL OR OIL COATS THE SAMPLE PROBE AND AFFECTS THE PLACEMENT OF THE SAMPLE IN THE CUVETTE. CONSEQUENTLY, NO OR TOO LITTLE SAMPLE IS AVAILABLE FOR THE REACTION.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED AN ISSUE WITH ANALYZER ALARMS AND QUESTIONABLE LOW RESULTS FOR MULTIPLE ASSAYS. THE ISSUE OCCURRED ON TWO COBAS 8000 C 502 MODULES AT THIS SITE. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE OTHER ANALYZER. AFTER A REPORTED LOW C-REACTIVE PROTEIN (CRP) RESULT WAS QUESTIONED BY A PHYSICIAN AND A HIGHER RESULT WAS OBTAINED UPON REPEAT TESTING, THE CUSTOMER DECIDED TO REPEAT TESTING FOR ABOUT 200 SAMPLES. OF THE DATA PROVIDED FOR FOUR PATIENT SAMPLES TESTED ON THIS ANALYZER, ONLY THE RESULTS FOR THREE PATIENT SAMPLES WERE DISCREPANT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. INFORMATION CONCERNING IF ANY ERRONEOUS RESULTS OTHER THAN THE AFOREMENTIONED CRP RESULT WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CRP REAGENT LOT NUMBER WAS 202456; THE EXPIRATION DATE WAS NOT PROVIDED. THE REAGENT LOT NUMBERS AND EXPIRATION DATES FOR THE ALBUMIN AND CALCIUM REAGENTS WERE REQUESTED BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE HAD DESCENDED INTO THE GEL OF THE SAMPLE TUBES.

    Patients

    Seq Age Sex Outcome Treatment
    1