BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 4765416 · Received May 12, 2015

    Report

    Report Number
    1823260-2015-03448
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 28, 2015
    Report Date
    June 12, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED: PATIENT 2 HAD TREATMENT CHANGED ON (B)(6) 2015. THE PHYSICIAN STOPPED THE VITAMIN D SUPPLEMENT. PATIENT 3 HAD TREATMENT CHANGED ON (B)(6) 2015. THE PHYSICIAN REDUCED THE VITAMIN D SUPPLEMENT DOSE FROM 2 CAP/WEEK TO 1 CAP/WEEK.

    Additional Manufacturer Narrative · 1

    THE FIBRIN IN THE MEASURING CELL WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. AFTER THE SERVICE ACTIONS, NO FURTHER ISSUES WERE NOTED AND THE INSTRUMENT WORKED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(4) 2015, THE CUSTOMER FOUND THE QC TO BE OUT OF THE ACCEPTABLE RANGE. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND FOUND FIBRIN IN THE MEASURING CELL. HE REPLACED THE MEASURING CELL AND RAN PERFORMANCE TESTING, CALIBRATION, AND QC WHICH PASSED. THE CUSTOMER THEN REPEATED SAMPLES TESTED ON (B)(6) 2015. OF THE DATA PROVIDED FOR EIGHT PATIENT SAMPLES, THE RESULTS FOR SEVEN WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL VITAMIN D RESULT WAS 52.01 NG/ML AND REPEAT RESULT WAS 29.17 NG/ML. THE INITIAL PARATHYROID HORMONE (PARATHORMONE, PARATHYRIN) -PTH, INTACT RESULT WAS 47.57 PG/ML AND THE REPEAT RESULT WAS 76.35 NG/ML. PATIENT SAMPLE 2 INITIAL VITAMIN D RESULT WAS 55.47 NG/ML AND THE REPEAT RESULT WAS 26.89 NG/ML. THIS PATIENT WAS A (B)(6) FEMALE. PATIENT SAMPLE 3 INITIAL VITAMIN D RESULT WAS 50.03 NG/ML AND THE REPEAT RESULT WAS 19.64 NG/ML. THIS PATIENT WAS A (B)(6) FEMALE. PATIENT SAMPLE 4 INITIAL VITAMIN B12 RESULT WAS <30.00 PG/ML AND THE REPEAT RESULT WAS 712.40 PG/ML. THIS PATIENT WAS A (B)(6) FEMALE. PATIENT SAMPLE 5 INITIAL VITAMIN B12 RESULT WAS 1142 PG/ML AND THE REPEAT RESULT WAS 644.20 PG/ML. THIS PATIENT WAS A (B)(6) FEMALE. PATIENT SAMPLE 6 INITIAL PTH RESULT WAS 371.70 PG/ML AND THE REPEAT RESULT WAS 678.20 NG/ML. THIS PATIENT WAS A (B)(6) FEMALE. PATIENT SAMPLE 7 INITIAL VITAMIN B12 RESULT WAS 794 PG/ML AND THE REPEAT RESULT WAS 332.50 PG/ML. THIS PATIENT WAS A (B)(6) MALE. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE VITAMIN B12 REAGENT LOT NUMBER WAS 183415 WITH AN EXPIRATION DATE OF 02/28/2016. THE REAGENT LOT NUMBERS AND EXPIRATION DATES FOR THE OTHER ASSAYS WERE REQUESTED, BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308932 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR