BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3021605 · Received March 26, 2013

    Report

    Report Number
    1823260-2013-01848
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 8, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED A SAMPLE FOR EVALUATION, WHICH WAS MEASURED WITH CREAJ AND A GAMMOPATHY PANEL. THE INVESTIGATION DETERMINED THERE WAS AN EXTREMELY ELEVATED IGM AND THE KAPPA/LAMBDA RATIO WAS ABOVE THE NORMAL RANGE. THE REACTION KINETICS WERE UNUSUAL AND INDICATED THE FORMATION OF A TURBIDITY AFTER THE SAMPLE WAS PIPETTED. GAMMOPATHY INTERFERENCE IS MENTIONED IN THE PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. FOR MEDWATCH ON QUESTIONABLE CREAJ RESULTS WITH C501 SERIAL NUMBER (B)(4), REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR CREATININE JAFFE GEN 2 (CREAJ) ON ONE PATIENT SAMPLE. THE CUSTOMER USED A PATIENT SAMPLE AS A PATIENT CONTROL BETWEEN THE INTEGRA 400+ (I400+) AND THE COBAS 6000 C501 (C501). ALL SAMPLE RESULTS CORRELATE BETWEEN THE TWO INSTRUMENTS EXCEPT FOR CREAJ. ALL RESULTS ARE IN MG/DL. THE ORIGINAL RESULT ON C501 SERIAL NUMBER (B)(4) WAS 2.0. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS THEN RUN ON I400+ AND GENERATED AN ORIGINAL RESULT OF 1.0, AND A REPEAT RESULT OF 1.1. THE SAMPLE WAS THEN RE-RUN ON THE C501 AND GENERATED A RESULT OF 2.1. THE CUSTOMER DOES NOT KNOW WHICH RESULTS ARE THE CORRECT RESULTS. THERE WAS NO ADVERSE EVENT. THE CUSTOMER INDICATED THAT THE PATIENT CONTROL SAMPLES FROM (B)(6) 2013 HAVE ALL PERFORMED AND CORRELATED WELL. THE CUSTOMER BELIEVES THE ISSUE TO BE SAMPLE SPECIFIC. THE LOT OF CREAJ REAGENT IN USE WAS 67159701, WITH AN EXPIRATION DATE OF 07/31/2014. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CUSTOMER SUSPECTED THE PATIENT SAMPLE AND A POSSIBLE MEDICATION CROSS REACTION. HE CHECKED THE SAMPLING AND INSTRUMENT PERFORMANCE. THE CUSTOMER ALSO PERFORMED CHECKS AND DID A PRECISION RUN. THE RESULTS WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124350 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 089 YR