BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3987148 · Received August 7, 2014

    Report

    Report Number
    1823260-2014-05961
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 4, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE NEGATIVE RESULTS WERE CONFIRMED BY THE INVESTIGATION AND TWO ADDITIONAL ASSAYS, THE NEGATIVE RESULTS OBTAINED BY THE CUSTOMER WERE CONSIDERED TO BE CORRECT. A NEGATIVE RESULT IN ELECSYS HSV-1 IGG DOES NOT COMPLETELY RULE OUT THE POSSIBILITY OF AN INFECTION WITH HSV-1 AS INDIVIDUALS MAY NOT EXHIBIT ANY DETECTABLE IGG ANTIBODIES AT THE EARLY STAGE OF AN ACUTE INFECTION. FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE HSV IS GLYCOPROTEIN G (GG) DEFICIENT (0.2 % HSV ISOLATES WERE GG DEFICIENT).

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS ENCEPHALOPATHY. THE CUSTOMER BELIEVED THE MOTHER OF THE PATIENT WAS INFECTED BY HERPES, BUT THEY DID NOT HAVE ANY PROOF. THE MEDICATION ACICLOVIR WAS STARTED WHEN THE PATIENT WAS BORN.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE SAMPLE DRAWN FROM THE PATIENT ON (B)(6) 2014 WAS SUBMITTED FOR INVESTIGATION. THE NEGATIVE HSV-1 IGG RESULT WAS CONFIRMED BY THE ROCHE METHOD AND TWO COMPETITOR ASSAYS (FOCUS AND MIKROGEN).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE IGG ANTIBODIES TO HERPES SIMPLEX VIRUS TYPE 1 (HSV-1 IGG) RESULTS FOR ONE PATIENT WHEN COMPARED TO OTHER METHODOLOGIES. THE HSV-1 IGG RESULTS FROM THE ANALYTICAL E MODULE WERE: SAMPLE 1: (B)(6) 2014: 0.065 COI-NEGATIVE. SAMPLE 2: (B)(6) 2014: 0.065 COI-NEGATIVE. SAMPLE 3: (B)(6) 2014: 0.065 COI-NEGATIVE. SAMPLE 1 AND SAMPLE 2 WERE SENT TO ANOTHER HOSPITAL AND TESTED ON A LIAISON (DIASORIN) ANALYZER. SAMPLE 1 RESULT WAS HSV-1 IGG: POSITIVE. SAMPLE 2 RESULT WAS HSV-1 IGG: POSITIVE. SAMPLE 1 WAS SENT TO ANOTHER HOSPITAL AND TESTED ON AN IMMULITE (SIEMENS). THE RESULT WAS HSV-1 IGG: POSITIVE. THE HSV-1 IGG RESULTS FROM THE ANALYTICAL E MODULE WERE REPORTED OUTSIDE THE LABORATORY. NO RESULTS WERE REPORTED TO THE PHYSICIANS AND THE LABORATORY EXPLAINED THAT THE SAMPLES WERE UNDER INVESTIGATION. NO ADVERSE EVENT WAS REPORTED FOR THE PATIENT. THE HSV-1 IGG REAGENT LOT NUMBER WAS 174277. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463885 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 007 MO ACICLOVIR