BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2614462 · Received June 13, 2012

    Report

    Report Number
    1823260-2012-03120
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    May 16, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR E-MODULE E170 FOR FIVE PATIENTS. PATIENT ONE HAD AN INITIAL HCGB RESULT OF 8.43 IU/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2012, THE SAMPLE WAS TESTED ON A STAND- ALONE E170 ANALYZER, SERIAL NUMBER (B)(4), AND THE RESULT WAS 0.358 IU/L. THE SAMPLE WAS TESTED ON THE ORIGINAL E170 AFTER THE SERVICE ENGINEER'S VISIT AND THE RESULT WAS 0.252 IU/L ACCOMPANIED BY A DATA FLAG. PATIENT TWO, A FEMALE BORN ON (B)(6), HAD AN INITIAL RESULT OF 30.68 IU/L. IT WAS REPORTED OUTSIDE THE LABORATORY AS 31 IU/L. THE PATIENT WAS ADMITTED TO THE CHILDREN'S WARD BASED ON THE POSITIVE HCGB RESULT. ON (B)(6) 2012, THE REPEAT RESULT FROM THE STAND-ALONE E170 ANALYZER WAS 0.100 IU/L ACCOMPANIED BY A DATA FLAG. THE PATIENT WAS DISCHARGED BASED ON THE NEGATIVE HCGB RESULT. PATIENT THREE, A FEMALE BORN ON (B)(6), HAD AN INITIAL RESULT OF 5.36 IU/L. IT WAS REPORTED OUTSIDE THE LABORATORY AS 5 IU/L. ON (B)(6) 2012, THE REPEAT RESULT FROM THE STAND-ALONE E170 ANALYZER WAS 0.100 IU/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS TESTED ON THE ORIGINAL E170 AFTER THE SERVICE ENGINEER'S VISIT AND THE RESULT WAS 0.100 IU/L ACCOMPANIED BY A DATA FLAG. PATIENT FOUR, A FEMALE BORN ON (B)(6), HAD AN INITIAL RESULT OF 6.34 IU/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2012, THE REPEAT RESULT FROM THE STAND-ALONE E170 ANALYZER WAS 0.100 IU/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS TESTED ON THE ORIGINAL E170 AFTER THE SERVICE ENGINEER'S VISIT AND THE RESULT WAS 0.100 IU/L ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2012, THE FIFTH PATIENT, A FEMALE BORN ON (B)(6), HAD AN INITIAL RESULT OF 8.95 IU/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT FROM THE ORIGINAL ANALYZER WAS 0.812 IU/L. THE CUSTOMER STATED "THE SAMPLE WAS REPEATED AGAIN AND ALSO ON ANOTHER ANALYZER AND STILL GAVE THE RESULT OF <1". THE PATIENTS WERE NOT HARMED AND THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE SERVICE ENGINEER REPLACED THE PINCH TUBING AND PINCH TUBE NOZZLES. HE REPLACED AND ADJUSTED THE GEAR PUMP HEAD. THE ADJUSTED THE LIQUID LEVEL DETECTION. HE RESEATED THE MIX PADDLE AND CHECKED MIXING. HE VERIFIED THE SYSTEM VOLUME CHECK. HE DECONTAMINATED THE PRECLEAN, DISPENSE, AND ASPIRATE LINES. HE BLEACHED THE WASTE LINES. HE VERIFIED QUALITY CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR