BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS GLUCOSE REAGENT

    MDR report key: 3795003 · Received May 7, 2014

    Report

    Report Number
    8020879-2014-00002
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOTTLES OF GLUCOSE REAGENT WERE SENT BACK TO BECKMAN COULTER (BEC) FOR EVALUATION. VISUAL INSPECTION OF THE REAGENTS DID NOT SHOW CONSISTENT PARTICULATES. THE REAGENTS PASSED BOTH CALIBRATION AND QUALITY CONTROL (QC.) MALFUNCTION OF THE GLUCOSE REAGENT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TROUBLESHOOTED THE INSTRUMENT WITH BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) AND FOUND THAT THE GLUM REAGENT CONTAINED WHITE PRECIPITATE. THE CUSTOMER CHANGED TO A NEW LOT OF REAGENT. THE BEC FIELD SERVICE ENGINEER (FSE) DISPATCHED TO THE SITE EVALUATED THE INSTRUMENT. THE FSE DID NOT FIND ANY HARDWARE FAILURES, BUT PERFORMED GLUM MAINTENANCE TO PREVENT ANY FURTHER ISSUES WITH PRECIPITATE. ALL ASSOCIATED MDRS: 8020879-2014-00003 AND 8020879-2014-00004.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING INCORRECT GLUCOSE (GLUM) RESULTS FOR 176 PATIENTS GENERATED BY TWO UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZERS ON THREE DATES. THIS REPORT REFERENCES THE EVENT THAT OCCURRED ON (B)(6) 2014 AND INVOLVED A UNICEL® DXC 800 PRO SYNCHRON® SYSTEM SERIAL NUMBER (B)(4); PLEASE REFER TO MDR 8020879-2014-00003 FOR THE EVENT THAT OCCURRED ON (B)(6) 2015 AND MDR 8020879-2014-00004 FOR THE EVENT THAT OCCURRED ON (B)(6) 2014. ON (B)(6) 2014, GLUM RESULTS FOR NINE PATIENTS WERE INCORRECT AND REPORTED OUT OF THE LABORATORY. THE PATIENT SAMPLES WERE LATER RETESTED AND GLUM RESULTS WERE CORRECTED. THE CUSTOMER IS NOT AWARE OF ANY CHANGE TO PATIENT TREATMENT DUE TO INCORRECT RESULTS. A REMOTE REVIEW OF QUALITY CONTROL (QC) DATA SHOWED THAT ON THE DAY OF THE EVENT, GLUM QC RESULTS WERE OUT OF SPECIFICATION ON AN INITIAL RUN AND WERE WITHIN SPECIFICATION UPON RERUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276573 SYNCHRON® SYSTEMS GLUCOSE REAGENT GLUCOSE OXIDASE, GLUCOSE CGA BECKMAN COULTER NA T310051

    Patients

    Seq Age Sex Outcome Treatment
    1