BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01624

    MDR report key: 6770441 · Received August 7, 2017

    Report

    Report Number
    1823260-2017-01624
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 13, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF THE EVENT WAS UPDATED. A REVIEW OF THE ALARM TRACE SHOWS SEVERAL "ABNORMAL SAMPLE ASPIRATION" MESSAGES. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. A POSSIBLE ROOT CAUSE IS THAT THERE WAS FOAM ON THE SAMPLE.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT ASKU: THE PATIENT IS DOCUMENTED AS BEING (B)(6) AND (B)(6) OLD. CLARIFICATION OF THE CORRECT AGE HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS LOW RESULT FOR 1 PATIENT TESTED FOR ELECSYS HCG + BETA TEST SYSTEM (HCG + B) ON A COBAS 8000 E 602 MODULE. THE INITIAL HCG + B RESULT WAS 0.277 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 258.2 MIU/ML. THE REPEAT RESULT WAS CONSIDERED TO BE CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HCG + B REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS NOT PROVIDED. THE QUALITY CONTROL (QC) RESULTS WERE ACCEPTABLE. THE PINCH TUBE WAS LAST REPLACED ON (B)(6) 2017. LIQUID FLOW CLEANING IS PERFORMED EVERY 3 DAYS. INSTRUMENT PERFORMANCE TEST RESULTS WERE ACCEPTABLE. THE POSSIBLE ROOT CAUSE OF THE ISSUE MAY HAVE BEEN FOAM ON THE SAMPLE AS A BUBBLE WAS DETECTED ON THE SURFACE OF THE SAMPLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR