BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FOLATE III

    MDR report key: 14675980 · Received June 13, 2022

    Report

    Report Number
    1823260-2022-01710
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 19, 2022
    Report Date
    June 21, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGN
    PMA / PMN Number
    K082340
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS UPDATED THE PATIENT DATA AND THE CORRECT INITIAL VALUES HAVE BEEN PROVIDED. RELEVANT TEST DATA FOR SOME OF THE PATIENT SAMPLES WAS ALSO PROVIDED. SEE ATTACHMENT FOR ALL PATIENT DATA. THE REPEAT VALUES FOR SAMPLE IDS 90194 AND 90195 WERE MEASURED ON 20-MAY-2022. ALL OTHER VALUES WERE MEASURED ON 19-MAY-2022. CALIBRATION DATA FROM 25-MAR-2022 TO 19-MAY-2022 WAS PROVIDED FOR FOLATE REAGENT LOT 596881. THE CALIBRATION SIGNALS WERE LOWER THAN EXPECTED AND WERE DECREASING OVER TIME. FROM THE CALIBRATION DATA, IT WAS NOT EVIDENT IF SOME CALIBRATIONS FAILED, BUT FAILED CALIBRATIONS WERE SUGGESTED ACCORDING TO THE CUSTOMER'S COMMENTS AND THE PROVIDED QUALITY CONTROL DATA. QUALITY CONTROL DATA FROM 10-APR-2022 TO 24-MAY-2022 WAS PROVIDED. MOST VALUES WERE WITHIN ACCEPTABLE RANGES, HOWEVER THERE WERE SEVERAL OUT OF RANGE HIGH VALUES FOR ALL CONTROL LEVELS. SEVERAL CONTROL MEASUREMENTS PERFORMED WITH ALL CONTROL LEVELS WERE OUTSIDE OF RANGE ON THE DAY OF THE EVENT. TWO LEVELS OF CONTROL WERE NOT MEASURED ON 18-MAY-2022; ONLY ONE LEVEL OF CONTROL WAS MEASURED THAT DAY AND IT WAS WITHIN RANGE. PER PRODUCT LABELING: "CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION. THE CONTROL INTERVALS AND LIMITS SHOULD BE ADAPTED TO EACH LABORATORY¿S INDIVIDUAL REQUIREMENTS. VALUES OBTAINED SHOULD FALL WITHIN THE DEFINED LIMITS. EACH LABORATORY SHOULD ESTABLISH CORRECTIVE MEASURES TO BE TAKEN IF VALUES FALL OUTSIDE THE DEFINED LIMITS. IF NECESSARY, REPEAT THE MEASUREMENT OF THE SAMPLES CONCERNED." IT IS UNKNOWN HOW THE SAMPLES WERE STORED IN BETWEEN INITIAL AND REPEAT MEASUREMENTS. PER PRODUCT LABELING, THE STABILITY OF FOLATE AT ROOM TEMPERATURE (15-25 DEGREES CELSIUS) IS ONLY 2 HOURS. ALL SAMPLES WERE INITIALLY PROCESSED ON A MODULAR PRE-ANALYTICS SYSTEM PRIOR TO TESTING. INVESTIGATIONS HAVE CONFIRMED A SIGNAL LOSS FOR FOLATE REAGENT LOT 596881. IT IS VERY LIKELY THIS ISSUE CONTRIBUTED TO THE OBSERVED SAMPLE DISCREPANCIES AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR NINE PATIENT SAMPLES TESTED WITH THE ELECSYS FOLATE III ASSAYVER. 2 ON A COBAS 6000 E 601 MODULE. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY TO THE CORRESPONDING DOCTOR FOR ALL SAMPLES EXCEPT THE SAMPLES WITH IDENTIFIERS OF (B)(6). CORRECTED REPORTS WERE ISSUED FOR THE REPEAT VALUES. THE FOLATE REAGENT LOT NUMBER WAS 596881. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248515 ELECSYS FOLATE III ACID, FOLIC, RADIOIMMUNOASSAY CGN ROCHE DIAGNOSTICS E601 596881
    332126 ELECSYS FOLATE III ACID, FOLIC, RADIOIMMUNOASSAY CGN ROCHE DIAGNOSTICS E601 596881

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown