BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01577

    MDR report key: 6757468 · Received August 1, 2017

    Report

    Report Number
    1823260-2017-01577
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    July 12, 2017
    Report Date
    September 6, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER DID NOT REPLACE THE MIXING STATION. HE DETERMINED THAT THERE WAS CONTAMINATION OF THE SYSTEM AND PERFORMED DECONTAMINATION PROCEDURES. NO COMPLAINTS OF THE SAME NATURE HAVE NOT OCCURRED ON ANY LIKE INSTRUMENT AT THE CUSTOMER SITE WITHIN THE PAST 12 MONTHS. NO ABNORMAL TREND WAS OBSERVED OVER THE PAST 90 DAYS FOR THE WATER BATH ASSEMBLY OF THE ANALYZER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDL) ON A COBAS 6000 C (501) MODULE - C501. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STATED THAT OTHER PATIENT SAMPLES RESULTED NORMALLY. THE CUSTOMER BELIEVED THE ISSUE TO BE RELATED TO THE INSTRUMENT AS IT HAD HAPPENED BEFORE IN THE PAST. NO FURTHER DETAILS WERE PROVIDED REGARDING THIS PREVIOUS EVENT. THE SAMPLE INITIALLY RESULTED AS 113 MG/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER, RESULTING AS 43 MG/DL. NO TREATMENT WAS PROVIDED TO THE PATIENT SINCE NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HDL REAGENT LOT NUMBER WAS 200767, WITH AN EXPIRATION DATE OF 07/31/2018. THE REAGENT HAD BEEN IN USE ON THE ANALYZER SINCE (B)(6) 2017. THE FIELD SERVICE ENGINEER FOUND CONTAMINATION IN THE INSTRUMENT. HE PERFORMED A DECONTAMINATION OF THE INSTRUMENT. HE CLEANED THE CIRCULATION PATHS, INCLUDING THE AIR TRAP AND LAMP HOLDER. HE REPLACED A VALVE. HE RAN PHOTOMETRIC TESTS AND THESE PASSED. THE CUSTOMER RAN QUALITY CONTROLS AND THESE WERE WITHIN LABORATORY SPECIFICATIONS. PRECISION STUDIES WERE PERFORMED AND THESE WERE WITHIN SPECIFICATION. THE CUSTOMER ALSO NOTED THAT THE ENGINEER CLEANED THE INCUBATOR BATH AND INFORMED THE CUSTOMER THAT THERE COULD POTENTIALLY BE AN ISSUE WITH THE MIXING STATION. PARTS WERE ORDERED TO REPLACE THE MIXING STATION.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR