BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-00269

    MDR report key: 6321972 · Received February 10, 2017

    Report

    Report Number
    1823260-2017-00269
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 10, 2017
    Report Date
    February 23, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    MEDWATCH FIELD D4 SERIAL NUMBER HAS BEEN UPDATED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR UA2 URIC ACID VER.2 (UAC2) ON A COBAS 6000 C (501) MODULE - C501. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. IT WAS STATED THAT THE LOW RESULT DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE INITIALLY RESULTED AS 0.026 MMOL/L. THE DATE OF INITIAL TESTING WAS NOT PROVIDED. THE SAMPLE WAS COLLECTED ON (B)(6) 2017. THE SAMPLE WAS REPEATED, RESULTING AS 0.269 MMOL/L ON (B)(6) 2017. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE UAC2 REAGENT LOT NUMBER WAS 172896. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE MIXER WAS FOUND TO BE WITHIN SPECIFICATIONS. CALIBRATIONS WERE WITHIN ACCEPTABLE LIMITS AND CONTROLS WERE WITHIN SPECIFICATIONS. SAMPLES WERE TESTED FROM PRIMARY TUBES WHICH WERE PROCESSED ON A COBAS P612 PRE-ANALYTICS SYSTEM.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR