BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01995

    MDR report key: 6867929 · Received September 15, 2017

    Report

    Report Number
    1823260-2017-01995
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    July 20, 2017
    Report Date
    October 9, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE FIELD APPLICATION SPECIALIST STATED THAT THE ANALYZER WAS WORKING FINE. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE INSUFFICIENT ELECTROMAGNETIC INTERFERENCE LAB COMPLIANCE, SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE.

    Additional Manufacturer Narrative · 1

    (B)(6). (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 STAT ASSAY (TNTHSST) ON A COBAS 6000 E 601 MODULE (E601). THE SAMPLE INITIALLY RESULTED AS 69.73 PG/ML AND THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PHYSICIANS. THE PHYSICIANS REQUESTED THE COLLECTION OF A SECOND SAMPLE. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED, RESULTING AS 7.24 PG/ML. THE ORIGINAL SAMPLE WAS THEN REPEATED TWICE ON (B)(6) 2017, RESULTING AS 8.24 PG/ML AND 6.84 PG/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE TNTHSST REAGENT LOT NUMBER WAS 182907. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. QUALITY CONTROL RESULTS FROM THE DAY OF THE EVENT WERE WITHIN SPECIFIED LIMITS. CENTRIFUGATION G-FORCE WAS FOUND TO BE BELOW RECOMMENDED TUBE MANUFACTURER RECOMMENDATIONS. UPON REVIEW OF THE ALARM TRACE, SOME LIQUID LEVEL DETECTION ERRORS COULD BE SEEN ON (B)(6) 2017, BUT NONE ON THE DAY OF THE EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR