BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02033

    MDR report key: 6882258 · Received September 21, 2017

    Report

    Report Number
    1823260-2017-02033
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 21, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.100 MIU/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY TO THE DOCTOR WHO QUESTIONED THE RESULT. THE REPEAT RESULT WITH A 1:100 DILUTION WAS 20539 MIU/ML. THE SAMPLE WAS ALSO REPEATED ON ANOTHER ANALYZER WITH A 1:100 DILUTION AND THE RESULT WAS 21049 MIU/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE DID FIND THE SIPPER NOZZLE SPRING MISSING FROM THE ASSEMBLY AND THE SAMPLE PROBE ASSEMBLY SET SCREWS WERE LOOSE WHICH CAUSED A SMALL AMOUNT OF PLAY IN THE HORIZONTAL MOTION. HE TIGHTENED THE SET SCREWS, REPLACED THE MISSING SPRING, AND REALIGNED THE SAMPLE PROBE ASSEMBLY. HE RAN PERFORMANCE TESTING AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER RAN CALIBRATION AND QC WHICH WERE ALL WITHIN SPECIFICATIONS. AS THE CUSTOMER DID NOT REPORT ANY FURTHER ISSUES, IT WAS DETERMINED THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR