BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2956982 · Received February 12, 2013

    Report

    Report Number
    1823260-2013-00829
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 26, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. CALIBRATION AND QUALITY CONTROLS WERE WITHIN EXPECTATIONS. A GENERAL REAGENT ISSUE WAS NOT OBVIOUS. INSTRUMENT CHECKS DID NOT SHOW EVIDENCE OF AN INSTRUMENT RELATED PROBLEM. FURTHER ROOT CAUSE ANALYSIS WAS NOT POSSIBLE WITH THE LITTLE AMOUNT OF DATA PROVIDED. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN PLUS THE SS-SUBUNIT (HCG+SS). THE SAMPLE INITIALLY RESULTED AS 68.74 MIU/ML ACCOMPANIED BY A DATA FLAG AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE ER AS 69 MIU/ML. A NURSE CALLED TO ASK FOR THE RESULT TO BE VERIFIED. THE SAMPLE WAS THEN RUN ON AN E601 ANALYZER WHERE IT RESULTED AS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE E601 ANALYZER AT A 1:100 DILUTION, RESULTING AS 136184 MIU/ML. A CORRECTED REPORT WAS ISSUED FOR THE REPEAT VALUE OF 136184 MIU/ML. THE CUSTOMER THEN REPEATED THE SAMPLE ON THE ORIGINAL ANALYZER (E MODULE SERIAL NUMBER (B)(4)) ON (B)(6) 2013, RESULTING AS 10000 ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN AUTOMATICALLY REPEATED AT A 1:100 DILUTION BY THE ORIGINAL ANALYZER ON (B)(6) 2013, RESULTING AS 130007 MIU/ML ACCOMPANIED BY A DATA FLAG. BOTH REPEAT VALUES ON THE ORIGINAL ANALYZER AND THE E601 ANALYZER WERE BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE HCG+SS REAGENT LOT NUMBER WAS 16758402 WITH AN EXPIRATION DATE OF 07/31/2013. THE FIELD SERVICE REPRESENTATIVE WAS NOT ABLE TO DETERMINE A CAUSE. HE PERFORMED INSTRUMENT CHECKS. THE QUESTIONABLE SAMPLE WAS REPEATED BY THE OPERATOR MULTIPLE TIMES WITH ACCURATE RESULTS AND THE RESULTS COMPARED WITH 2 OTHER E MODULES. RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61793 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 025 YR