BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02349

    MDR report key: 6954547 · Received October 17, 2017

    Report

    Report Number
    1823260-2017-02349
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 8, 2017
    Report Date
    November 1, 2017
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE CUSTOMER DID NOT USE RECOMMENDED RACK ADAPTERS FOR 13 MM. DIAMETER TUBES. THIS COULD POTENTIALLY CAUSE A PIPETTING ISSUE. POSSIBLE ROOT CAUSES INCLUDE SAMPLE QUALITY AND INSUFFICIENT MAINTENANCE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (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 HCG + BETA TEST SYSTEM (HCGB) ON A COBAS E 411 IMMUNOASSAY ANALYZER (E411). THE PATIENT IS PREGNANT. THE SAMPLE INITIALLY RESULTED AS 0.134 IU/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2017, RESULTING AS > 10000 IU/L ACCOMPANIED BY A DATA FLAG AND WITH A 1:100 DILUTION, RESULTING AS 134846 IU/L ACCOMPANIED BY A DATA FLAG. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HCGB REAGENT LOT NUMBER WAS 210151. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. QUALITY CONTROLS PERFORMED ON (B)(6) 2017 WERE WITHIN RANGE, BUT THE CONTROL TRACE SHOWS HIGH INACCURACY. THE CALIBRATION PERFORMED ON (B)(6) 2017 WAS WITHIN EXPECTATIONS.

    Patients

    Seq Age Sex Outcome Treatment
    1