BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2484071 · Received March 8, 2012

    Report

    Report Number
    1823260-2012-01325
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 22, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A GENERAL REAGENT OR INSTRUMENT ISSUE IS NOT OBVIOUS AS ALL CALIBRATION AND QUALITY CONTROL DATA WAS ACCEPTABLE. A SYSTEM ISSUE WAS NOT SUSPECTED AS ALL PERFORMANCE TESTING WAS SUCCESSFUL. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FROM A "POUR OFF" TUBE WAS >10000 MIU/ML WITH A DATA FLAG ON ANALYTICAL E MODULE SERIAL NUMBER (B)(4). THE SAMPLE WAS AUTOMATICALLY REPEATED ON THIS E MODULE WITH A 1:100 DILUTION AND THE RESULT WAS 10 MIU/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE USER QUESTIONED THE RESULT AND RERAN THE ORIGINAL SAMPLE ON ANALYTICAL E MODULE SERIAL NUMBER (B)(4) AND THE RESULT WAS >10,000 MIU/ML WITH A DATA FLAG. THE SAMPLE AUTOMATICALLY REPEATED WITH A 1:100 DILUTION AND THE RESULT WAS 113085 MIU/ML WITH A DATA FLAG. THIS WAS THE RESULT THE USER REPORTED AS CORRECT. THE ORIGINAL "POUR OFF" TUBE WAS REPEATED AND THE RESULT WAS >10000 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH A 1:100 DILUTION AND THE RESULT WAS 116712 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG+SS REAGENT LOT NUMBER WAS 16250103 WITH AN EXPIRATION DATE OF 07/31/2012. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE ADJUSTED THE LIQUID LEVEL DETECTION (LLD) VOLTAGE, RAN PERFORMANCE TESTING AND TESTED SAMPLES AND ALL "POUR OFFS." HE OBSERVED THE SYSTEM WAS PERFORMING CORRECTLY AND AS PER SPECIFICATION. ALL SYSTEM CHECKS WERE SUCCESSFUL. THE USER RAN QUALITY CONTROL WITH ALL RESULTS ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1