BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04057

    MDR report key: 5047845 · Received September 1, 2015

    Report

    Report Number
    1823260-2015-04057
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 14, 2015
    Report Date
    October 13, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DATE OF THE EVENT WAS ACTUALLY (B)(6) 2015. THE UNIT OF MEASURE FOR THE REPEAT RESULTS ON THE VIDAS ANALYZER WAS IU/ML. PATIENT 1 WAS REPEATED ON (B)(6) 2015. PATIENT 2 WAS REPEATED ON (B)(6) 2015. THE REPEAT RESULT WAS ACTUALLY 24 IU/ML. PATIENT 2 WAS A (B)(6) YEAR OLD FEMALE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS WERE REPRODUCED. NO REAGENT SPECIFIC ISSUE COULD BE FOUND.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE SUBMITTED SAMPLES CONFIRMED THE TRUE RESULT FOR THE SAMPLES TO BE POSITIVE. A SPECIFIC ROOT CAUSE FOR DISCREPANCY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE IGG ANTIBODIES TO RUBELLA VIRUS RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. OF THE DATA PROVIDED FOR FOUR PATIENT SAMPLES, ONLY THE RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. THE SPECIFIC DATE OF TESTING WAS NOT PROVIDED. PATIENT 1 RESULT FROM COBAS E601 WAS 5.25 IU/ML (NON-REACTIVE). THE RESULT FOR THE SAME SAMPLE TESTED ON A MINI VIDAS WAS 31. PATIENT 2 RESULT FROM COBAS E601 WAS 7.77 IU/ML (NON-REACTIVE). THE RESULT FOR THE SAME SAMPLE TESTED ON A MINI VIDAS WAS 23. THE RESULTS FROM THE COBAS E601 WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENT WAS REPORTED. THE REAGENT LOT NUMBER WAS 182963. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR