BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01054

    MDR report key: 6578166 · Received May 19, 2017

    Report

    Report Number
    1823260-2017-01054
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 19, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS TROPONIN T HS ASSAY (TNTHS) ON A COBAS 6000 E 601 MODULE (E601). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TNTHS WAS 7.76 NG/ML. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2017, RESULTING AS 1122 NG/ML ON ANOTHER ANALYZER AND 1078 NG/ML ON THE ORIGINAL ANALYZER. NO ADVERSE EVENTS WERE ALLEGED. THE TNTHS REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE SAMPLE PROBE LIQUID LEVEL DETECTION, AND THIS WAS OK. HE CHECKED THE REAGENT CAP HOLDER, AND THIS WAS OK. HE ADJUSTED THE MIXER HEIGHT AND ADJUSTED THE HEIGHTS OF PROBES. THE MIS-ADJUSTMENTS FOUND BY THE FIELD SERVICE ENGINEER WOULD TYPICALLY LEAD TO POOR ACCURACY, BUT NOT TO SINGLE DISCREPANT RESULTS. A PRE-ANALYTIC SAMPLE HANDLING ISSUE IS MOST LIKELY, BUT THIS CAN NOT BE CONFIRMED BASED ON THE PROVIDED INFORMATION. NO FURTHER ISSUES WERE OBSERVED BY THE CUSTOMER.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR