BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02173

    MDR report key: 6910084 · Received October 3, 2017

    Report

    Report Number
    1823260-2017-02173
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 12, 2017
    Report Date
    December 11, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#:(B)(4).

    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.

    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 6000 E 601 MODULE (E601). THE SAMPLE INITIALLY RESULTED AS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND REPEATED, RESULTING AS 10.00 MIU/ML ACCOMPANIED BY A DATA FLAG. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR, WHO ASKED FOR THE SAMPLE TO BE REPEATED. THE SAMPLE WAS DILUTED 1:20 AND REPEATED ON (B)(6) 2017, RESULTING AS 24858 MIU/ML. THE DOCTOR SCANNED THE PATIENT AND CONFIRMED THE PATIENT WAS PREGNANT. THE PATIENT WAS ALSO TESTED WITH A URINE PREGNANCY TEST WHICH CONFIRMED THAT THE PATIENT WAS PREGNANT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HCGB REAGENT LOT NUMBER WAS 210151, WITH AN EXPIRATION DATE OF MAY 2018. THE FIELD SERVICE ENGINEER RAN PERFORMANCE TESTING.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR