BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-00359

    MDR report key: 6341273 · Received February 17, 2017

    Report

    Report Number
    1823260-2017-00359
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 27, 2017
    Report Date
    April 10, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE MOST LIKELY ROOT CAUSE WAS A PRE-ANALYTICAL ISSUE SUCH AS A TOO SHORT CLOTTING TIME RESULTING IN CLOT FORMATION. A MORE GENERAL POSSIBILITY COULD BE BUBBLES OR FOAM ON THE REAGENT SURFACE OR ON THE SYSTEM REAGENT SURFACE. BASED ON THE PROVIDED DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    CLARIFICATION WAS RECEIVED THAT THE REAGENT LOT NUMBER WAS ACTUALLY 172096. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH ELECSYS FT3 III RESULTS FOR FIVE PATIENT SAMPLES. THE SAMPLES WERE RETESTED ON ANOTHER COBAS E602 ANALYZER AND THEN REPEATED ON THE ORIGINAL COBAS E602 ANALYZER. PATIENT 1: INITIAL RESULT WAS 5.1 PG/ML, REPEAT RESULTS WERE 3.0 PG/ML AND 3.2 PG/ML. THE FOLLOWING PATIENTS WERE TESTED ON (B)(6) 2017. PATIENT 2: INITIAL RESULT WAS 7.3 PG/ML, REPEAT RESULTS WERE 2.1 PG/ML AND 2.1 PG/ML. PATIENT 3: INITIAL RESULT WAS 9.2 PG/ML, REPEAT RESULTS WERE 3.8 PG/ML AND 4.0 PG/ML. PATIENT 4: INITIAL RESULT WAS 3.9 PG/ML, REPEAT RESULTS WERE 2.1 PG/ML AND 2.2 PG/ML. PATIENT 5: INITIAL RESULT WAS 6.7 PG/ML, REPEAT RESULTS WERE 3.2 PG/ML AND 3.3 PG/ML. INFORMATION CONCERNING IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT IT WAS UNKNOWN. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 17902600. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. AN EFFECT DUE TO ELECTROSTATIC WAS SUSPECTED.

    Patients

    Seq Age Sex Outcome Treatment
    1