BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 8257517 · Received January 17, 2019

    Report

    Report Number
    1823260-2019-00226
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    November 22, 2018
    Report Date
    January 28, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE CUSTOMER'S CALIBRATION AND QC DATA. BASED ON THE TYPE OF SAMPLE TUBES THE CUSTOMER USES, THE CENTRIFUGATION TIME IS TOO SHORT AND THE CENTRIFUGATION TIME IS TOO HIGH. BETWEEN 01-OCT-2018 AND 02-JAN-2019, 27 SAMPLE ASPIRATION ALARMS AND 5 ABNORMAL SAMPLE PROBE MOVEMENT ALARMS WERE OBSERVED ON THE ALARM TRACE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED, THE MALFUNCTION IS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS PTH STAT IMMUNOASSAY (PTH STAT) ON A COBAS 6000 E 601 MODULE. PATIENT 1 INITIAL RESULT WAS 30.62 PG/ML. THIS DID NOT CORRESPOND TO THE PATIENT'S CLINICAL PICTURE SO THE SAMPLE WAS REPEATED WITH A RESULT OF 121.8 PG/ML. ON (B)(6) 2018 PATIENT 2 INITIAL RESULT WAS 32.40 PG/ML. ON (B)(6) 2018 THE SAMPLE WAS REPEATED WITH A RESULT OF 483.6 PG/ML. IT IS NOT KNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE HIGH RESULTS WERE BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE PTH STAT REAGENT LOT NUMBER WAS 302670. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50254 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1