BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II

    MDR report key: 3410556 · Received October 15, 2013

    Report

    Report Number
    1823260-2013-06312
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 31, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    PMA / PMN Number
    K061970
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DETAILS WERE REQUESTED BUT NOT PROVIDED. BASED UPON THE INFORMATION PROVIDED, THE SAMPLE DILUTED 1:1000 GAVE A RESULT OF 240000 IU/ML. IT IS KNOWN THAT SAMPLES ABOVE A CONCENTRATION OF 50000 IU/ML MAY BE AFFECTED BY A HIGH DOES HOOK EFFECT. THIS LIMITATION IS DOCUMENTED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE IMMUNOGLOBULIN E (IGE) RESULTS FOR ONE PATIENT ON THEIR E602 ANALYZER. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL IGE RESULT WAS 600 IU/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN THOUGHT THE RESULT WAS TOO LOW COMPARED TO THE PATIENT'S CONDITION. THE FIRST REPEAT RESULT WAS 600 IU/ML. THE SAMPLE WAS THEN DILUTED 1:10, AND THE RESULT WAS >2500 IU/ML. THE SAMPLE WAS THEN DILUTED 1:100, AND THE RESULT WAS >2500 IU/ML. THE SAMPLE WAS FINALLY DILUTED 1:1000, AND THE RESULT WAS 240000 IU/ML. IT WAS UNKNOWN WHICH REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULT. NO ADVERSE EVENT HAS BEEN REPORTED. THE IGE REAGENT LOT NUMBER WAS 168340 AND THE EXPIRATION DATE WAS 12/30/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527837 ELECSYS IGE II RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)21 JHR ROCHE DIAGNOSTICS NA 168340

    Patients

    Seq Age Sex Outcome Treatment
    1