BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRON GEN.2

    MDR report key: 6420522 · Received March 21, 2017

    Report

    Report Number
    1823260-2017-00600
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Date of Event
    March 1, 2017
    Report Date
    July 10, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIY
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, THE DIAGNOSTICALLY RELEVANT IRON BOUND TO TRANSFERRIN IS RELEASED DUE TO ACIDIC PH AND DETERGENT IN THE REACTION SOLUTION. IRON FROM OTHER SOURCES (HEMOGLOBIN, ENZYMES CONTAINING IRON-SULFUR CLUSTERS, ETC.) IS DIAGNOSTICALLY IRRELEVANT AND IS INTENTIONALLY NOT ASSESSED. THE DRUG IN THE SUPPLEMENTS CAN BIND IRON FROM THE SAMPLE. THIS PROCESS OCCURS IN THE PATIENT SAMPLE APART FROM THE ANALYZER, BUT IT LEADS TO LOWER IRON RESULTS BECAUSE THE IRON2 ASSAY DOES NOT DETECT THE DRUG BOUND IRON. A PRODUCT PROBLEM WAS NOT DETECTED. THE DEVICE OPERATES PER SPECIFICATION.

    Additional Manufacturer Narrative · 1

    FACILITY NAME CONTINUED - (B)(4). THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER IS QUESTIONING LOW RESULTS FOR 2 PATIENTS TESTED FOR IRON2 IRON GEN.2 (IRON2) ON A COBAS INTEGRA 800. THE CUSTOMER HAD REPORTED IRON2 RESULTS FOR 2 PATIENTS OUTSIDE OF THE LABORATORY WHERE THE RESULTS WERE QUESTIONED BY THE CLINICAL DOCTOR. SINCE THE CLINICAL DOCTOR QUESTIONED THE RESULTS, THE CUSTOMER DECIDED TO PERFORM A METHOD COMPARISON WITH 30 PATIENT SAMPLES BETWEEN THE INTEGRA 800 INSTRUMENT AND A HITACHI 7600 ANALYZER USING A WAKO REAGENT. BASED ON THE COMPARISON DATA PROVIDED, THE RESULTS FOR THESE 2 PATIENTS WERE ERRONEOUS. NO OTHER ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL IRON2 RESULT WAS 99 UG/DL ON THE INTEGRA 800. THE REPEAT RESULT FROM THE HITACHI 7600 ANALYZER USING WAKO REAGENT WAS 296 UG/DL. PATIENT 2 (FEMALE) INITIAL IRON2 RESULT WAS 120 UG/DL ON THE INTEGRA 800. THE REPEAT RESULT FROM THE HITACHI 7600 ANALYZER USING WAKO REAGENT WAS 442 UG/DL. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THESE PATIENTS WERE TAKING IRON SUPPLEMENTS SO THE CUSTOMER WAS AWARE THE IRON2 RESULTS COULD BE LOW DUE TO THIS. THE CUSTOMER IS WONDERING WHY THE WAKO REAGENT IS NOT AFFECTED THE SAME WAY. PRODUCT LABELING INDICATES THAT THE IRON2 TEST IS AFFECTED WHEN PATIENTS ARE TREATED WITH IRON SUPPLEMENTS OR METAL-BINDING DRUGS. IN THESE PATIENTS, THE DRUG-BOUND IRON MAY NOT PROPERLY REACT WITH THE REAGENT, WHICH CAN CAUSE LOW RESULTS. ROCHE CANNOT PROVIDE INFORMATION AS TO THE SPECIFICATIONS OR PERFORMANCE OF THE WAKO PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204425 IRON GEN.2 PHOTOMETRIC METHOD, IRON (NON-HEME) JIY ROCHE DIAGNOSTICS NA 17599301

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT 1 - IRON SUPPLEMENT| PATIENT 2 - IRON SUPPLEMENT