BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA IGA GEN 2

    MDR report key: 6187434 · Received December 19, 2016

    Report

    Report Number
    1823260-2016-02006
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 25, 2016
    Report Date
    January 30, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CZP
    PMA / PMN Number
    K040435
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER LATER CLARIFIED THAT THE PATIENT HAS AN ISOLATED DEFICIENCY OF IGA. THE FOLLOWING HISTORY OF THE PATIENT WAS PROVIDED: ON (B)(6) 2013 IGA RESULT SIEMENS: 3.0 MG/DL (REFERENCE RANGE: 40 TO 350 MG/DL), ON (B)(6) 2014 IGA RESULT SIEMENS: 4.0 MG/DL (REFERENCE RANGE: 40 TO 350 MG/DL), ON (B)(6) 2015 IGA RESULT ROCHE: 15.0 MG/DL (REFERENCE RANGE: 34 TO 305 MG/DL). INVESTIGATIONS DETERMINED THAT THERE IS NO EVIDENCE THAT SOMETHING WENT WRONG WITH THE IGA MEASUREMENT. THE DATA PROVIDED FROM THE PATIENT'S HISTORY ARE OLD AND THEREFORE QUESTIONABLE TO LINK TO THE CURRENT MEASURED DATA. IT SHOULD ALSO BE CONSIDERED THAT EXPECTED VALUES FOR CHILDREN INCREASES OVER TIME. CALIBRATION AND CONTROL VALUES LOOKED GOOD. THE PATIENT VALUE OF 24 MG/DL IS BELOW EXPECTED VALUES FOR CHILDREN AGED 9 YEARS (34 - 305 MG/DL).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR IGA-2 TINA-QUANT IGA GEN.2 (IGA) ON A COBAS 8000 C 702 MODULE (C702). THE SAMPLE RESULTED AS 24 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN EXPECTED A LOWER IGA RESULT DUE TO THE CLINICAL CONDITION OF THE PATIENT. THE SAMPLE WAS NOT RETESTED. THE PATIENT HAS A DISEASE THAT CAUSES A LACK OF IGA PRODUCTION, BUT THE CUSTOMER COULD NOT PROVIDE THE SPECIFIC DISEASE NAME. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE C702 ANALYZER WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837904 COBAS INTEGRA IGA GEN 2 IMMUNOGLOBULIN A CZP ROCHE DIAGNOSTICS NA 13162801

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR AMOXICILLIN| PREDNISONE