BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FERRITIN

    MDR report key: 8129707 · Received December 4, 2018

    Report

    Report Number
    1823260-2018-04621
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    September 25, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    PMA / PMN Number
    K971833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE REQUESTS WERE MADE FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER DID NOT WANT TO SEND IN THE PATIENT SAMPLE. SINCE NO SAMPLE WAS SUBMITTED, THE INVESTIGATION COULD NOT BE COMPLETED. PRODUCT LABELING STATES "THE ASSAY IS UNAFFECTED BY BIOTIN LEVELS < 250 NMOL/L OR < 50 NG/ML. SAMPLES SHOULD NOT BE TAKEN FROM PATIENTS RECEIVING THERAPY WITH HIGH BIOTIN DOSES (I.E. > 5 MG/DAY) UNTIL AT LEAST 8 HOURS FOLLOWING THE LAST BIOTIN ADMINISTRATION." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FOR 1 NEONATAL PATIENT TESTED FOR ELECSYS FERRITIN (FERRITIN) ON A COBAS 8000 E 602 MODULE. THIRTY MINUTES AFTER BEING BORN ON (B)(6) 2018, THE PATIENT PRESENTED WITH NEUROLOGICAL DEGRADATION WITH HYPOTONIA, SEVERE HYPOGLYCEMIA AND HEPATOCELLULAR INSUFFICIENCY. AT 12:25 A.M. ON (B)(6) 2018 THE PATIENT WAS TESTED FOR FERRITIN AND THE RESULT WAS 57,907 UG/L SUGGESTING HYPERFERRITINEMIA. THE EVENING OF (B)(6) 2018 BIOTIN TREATMENT WAS STARTED BASED ON A POTENTIAL METABOLIC DISEASE. ON (B)(6) 2018 AT 5:30 A.M. A NEW SAMPLE WAS OBTAINED AND THE FERRITIN RESULT HAD DECREASED TO 90 NG/L. THE REST OF THE TEST RESULTS WERE CONSISTENT WITH THE RESULTS FROM (B)(6) 2018. THE CUSTOMER SUSPECTS AN INTERFERENCE WITH BIOTIN AFFECTING THE FERRITIN RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969492 ELECSYS FERRITIN RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN JMG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA