BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01518

    MDR report key: 6737238 · Received July 24, 2017

    Report

    Report Number
    1823260-2017-01518
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    July 4, 2017
    Report Date
    September 1, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE DETERMINED THAT THE ISSUE IS MOST LIKELY PRE-ANALYTIC RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TRIGL TRIGLYCERIDES (TRIG) ON A COBAS 6000 C (501) MODULE - C501. THE SAMPLE INITIALLY RESULTED AS 27 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A PHYSICIAN CALLED TO COMPLAIN ABOUT THE RESULT, SO THE SAMPLE WAS REPEATED. VISIBLE FIBRIN WAS FOUND IN THE SAMPLE AND REMOVED. THE SAMPLE WAS THEN REPEATED TWICE, RESULTING AS 639 MG/DL AND 644 MG/DL. THE 644 MG/DL VALUE WAS CONSIDERED TO BE CORRECT. NO ADVERSE EVENTS WERE ALLEGED. THE TRIG REAGENT LOT NUMBER WAS 211609, WITH AN EXPIRATION DATE OF 01/31/2018. NO RELEVANT INSTRUMENT ALARMS WERE GENERATED AROUND THE TIME THAT THE SAMPLE WAS PIPETTED. A GENERAL REAGENT ISSUE COULD BE RULED OUT AS CALIBRATION AND QUALITY CONTROLS ARE ACCEPTABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR