BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3429056 · Received October 25, 2013

    Report

    Report Number
    1823260-2013-06570
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    October 8, 2013
    Report Date
    December 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. NO HARDWARE FAILURE WAS DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR MULTIPLE ANALYTES ON 4 DIFFERENT ANALYZERS: 2 P MODULES, 1 E MODULE, AND 1 CORE MODULE. ON THIS E MODULE, THERE WAS AN ERRONEOUS RESULT FOR THYROTROPIN (TSH) THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 5.71 UIU/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS REPEATED ON A DIFFERENT E MODULE ON (B)(6) 2013 WHERE IT RESULTED AS 2.64 UIU/ML. THE SAMPLE WAS ALSO REPEATED A SECOND TIME ON THE ORIGINAL E MODULE ON (B)(6) 2013, RESULTING AS 2.57 UIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER WAS ASKED, BUT DID NOT PROVIDE THE TSH REAGENT LOT NUMBER OR EXPIRATION DATE. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE RAN DIAGNOSTICS. HE CHECKED PROBES AND PROBE BATHS; THESE CHECKED OK. HE CHECKED THE GEAR PUMP PRESSURE AND THIS WAS OK. HE RAN A PRECISION STUDY AND THIS WAS OK. THE CUSTOMER RAN QUALITY CONTROLS AND ALL RECOVERED WITHIN RANGE. THE SYSTEM WAS FOUND TO BE OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548113 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1