BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01836

    MDR report key: 6824916 · Received August 28, 2017

    Report

    Report Number
    1823260-2017-01836
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 9, 2017
    Report Date
    November 1, 2017
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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

    FOR THE CALIBRATION ON (B)(6) 2017, ALL SIGNALS WERE WITHIN EXPECTATIONS. QUALITY CONTROL VALUES WERE ALSO WITHIN ACCEPTABLE RANGES ON (B)(6) 2017. THERE WAS NO OBVIOUS ISSUE WITH THE REAGENTS THAT WERE USED. THE SAMPLE VOLUME WAS AROUND 2 ML AND MAY HAVE BEEN TOO LOW. THE SAMPLE WAS INVERTED 2 TIMES AND THIS MAY NOT BE ENOUGH. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE MOST LIKELY ROOT CAUSE IS POOR SAMPLE QUALITY. OTHER POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE IMPROPER HANDLING OF THE REAGENT OR SYSTEM REAGENTS, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS VITAMIN D ASSAY (VITD) ON A COBAS E 411 IMMUNOASSAY ANALYZER (E411). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. AN ALIQUOT OF THE SAMPLE INITIALLY RESULTED AS 61.16 NG/ML. A SECOND ALIQUOT OF THE SAMPLE WAS REPEATED, RESULTING AS 29.25 NG/ML. THE ORIGINAL ALIQUOT WAS ALSO REPEATED, RESULTING AS 28.87 NG/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SAMPLE APPEARED TO BE CLEAR, WITHOUT ANY CLOTS. THERE WAS ADEQUATE SAMPLE VOLUME. THE VITD REAGENT LOT NUMBER WAS 211769. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER SUSPECTED THAT THE ISSUE WAS CAUSED BY ALIGNMENT OF THE PIPETTOR.

    Patients

    Seq Age Sex Outcome Treatment
    1