BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02065

    MDR report key: 6889669 · Received September 25, 2017

    Report

    Report Number
    1823260-2017-02065
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    August 31, 2017
    Report Date
    October 12, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. POSSIBLE ROOT CAUSES FOR THIS EVENT INCLUDE SAMPLE QUALITY, IMPROPER HANDLING OF THE REAGENT OR SYSTEM REAGENTS, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE MEASURING CELLS OF A COBAS 8000 E 801 MODULE (E801) ANALYZER WERE REPLACED ON (B)(6) 2017. THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS VITAMIN D GEN. 2 ASSAY (VITD) ON TWO E801 ANALYZERS. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO OTHER ISSUES WERE OBSERVED BY THE CUSTOMER SINCE THIS INCIDENT. THIS MEDWATCH WILL APPLY TO E801 ANALYZER SERIAL NUMBER (B)(4). PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO E801 ANALYZER SERIAL NUMBER (B)(4). THE SAMPLE WAS INITIALLY TESTED ON E801 ANALYZER SERIAL NUMBER 1607-07 AND THE RESULT WAS 250 NG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN REPEATED TWICE ON E801 ANALYZER SERIAL NUMBER (B)(4) AND THE RESULTS WERE 70.2 NG/ML AND 41.5 NG/ML. ON (B)(6) 2017, THEY REPEATED THE SAMPLE TWO MORE TIMES ON E801 ANALYZER SERIAL NUMBER (B)(4) AND THE RESULTS WERE 37.9 NG/ML AND 30.3 NG/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. QUALITY CONTROL RESULTS WERE WITHIN SPECIFIED RANGES. THE CUSTOMER COULD NOT EXCLUDE THAT THE ISSUE WAS RELATED TO A SAMPLE OF LESSER QUALITY EVEN THOUGH NO FIBRIN WAS OBSERVED IN THE SAMPLE AFTER VISUAL INSPECTION. UPON REVIEW OF AN ALARM TRACE, ABNORMAL SAMPLE ASPIRATION AND SAMPLE SHORT ALARMS WERE SEEN ON (B)(6) 2017. REAGENT SHORT MESSAGES COULD BE SEEN ON (B)(6) 2017.

    Patients

    Seq Age Sex Outcome Treatment
    1