BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUATTRO PREMIER XE MASS SPECTROMETER

    MDR report key: 1640917 · Received March 24, 2010

    Report

    Report Number
    9616673-2010-00001
    Event Type
    Death
    Date Received
    March 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    WATERS CORP
    Product Code
    OQS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE (B) (6), 2010 NEWS RELEASE INDICATED THAT PTS WITH CYCLOSPORINE TESTING PERFORMED BETWEEN (B) (6) 2009 AND (B) (6) 2010 MAY HAVE BEEN AFFECTED. THE (B) (6) 2010 (B) (6) BROADCASTING CORP (B) (6) NEWS ARTICLE STATED THAT THE (B) (6) PT WAS ADMITTED TO INTENSIVE CARE ON (B) (6) 2010. WATERS BECAME AWARE THAT PTS MAY HAVE BEEN AFFECTED BY LOWER THAN EXPECTED CYCLOSPORINE RESULTS ON (B) (6) 2010. EVALUATION SUMMARY: ON MARCH 5, 2010, A WATERS SERVICE ENGINEER ASSESSED THE PERFORMANCE OF THE QUATTRO PREMIER INSTALLED AT THE (B) (6) LABORATORY AND DETERMINED IT WAS FUNCTIONING WITHIN SPECIFICATION. USE OF DEVICE: THE QUATTRO PREMIER IS A PIECE OF CAPITAL EQUIPMENT AND IS NOT DISPOSABLE. THE PARTICULAR QUATTRO PREMIER AT (B) (6) WAS INSTALLED NEW IN APRIL 2009. (B) (6) PUT THE QUATTRO PREMIER INTO ROUTINE SERVICE FOR CYCLOSPORINE TESTING IN JUNE 2009. WATERS DID NOT HAVE ANY COMPLAINTS REGARDING THE INSTRUMENT PERFORMANCE UNTIL FEBRUARY 2010. DEVICE INFO: THE ANALYZER IDENTIFIED IN THE (B) (6) PRESS RELEASE IS A QUATTRO PREMIER. THIS INSTRUMENT IS MANUFACTURED BY WATERS CORP. THE QUATTRO PREMIER IS A TANDEM QUADRUPOLE MASS SPECTROMETER. THE QUATTRO PREMIER ISOLATES IONS BASED ON THE SPECIFIC MASS OF AN ANALYTE. THE QUATTRO PREMIER PERFORMS CONTROLLED FRAGMENTATION OF SELECTED IONS TO FORM A PRODUCT ION OF A SPECIFIC MASS. THE SPECIFIC PRODUCT IONS ARE USED TO GENERATE AN ELECTRICAL SIGNAL PROPORTIONAL TO THE CONCENTRATION OF THE ANALYTE. THE QUATTRO PREMIER IS PROVIDED NON-STERILE. THE QUATTRO PREMIER WAS COMMERCIALLY RELEASED ON JUNE 22, 2005. DEVICE INTENDED USE: THE QUATTRO PREMIER IS INTENDED AS BOTH A RESEARCH TOOL AND FOR GENERAL IN VITRO DIAGNOSTIC USE. WATERS SELLS THE QUATTRO PREMIER TO A VARIETY OF INDUSTRIES, INCLUDING CLINICAL DIAGNOSTIC LABORATORIES. CLINICAL DIAGNOSTIC LABORATORIES MAY CHOOSE TO BUY A WATERS INSTRUMENT AND VALIDATE THEIR OWN ASSAY ON IT. IN THIS CASE, (B) (6) CHOSE TO UTILIZE THE INSTRUMENT FOR CYCLOSPORINE QUANTIFICATION. OTHER DEVICES USED: ACCORDING TO WATERS RECORDS, (B) (6) WAS USING THE (B) (4) SYMBIOSIS INSTRUMENT FOR CHROMATOGRAPHY SEPARATION. THIS INSTRUMENT WAS COUPLED TO THE QUATTRO PREMIER. WATERS WILL SUBMIT A FOLLOW-UP TO THIS MDR IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT RELATES TO THE WATERS QUATTRO PREMIER XE MASS SPECTROMETER (QUATTRO PREMIER) INSTALLED AT (B) (6). (B) (6) WAS QUANTIFYING CYCLOSPORINE USING A HOME-BREW ASSAY RUN ON THE QUATTRO PREMIER COUPLED TO A (B) (4) SYMBIOSIS INSTRUMENT. (B) (6) HAS PUBLISHED NEWS REPORTS ON ITS WEBSITE STATING THAT 212 PTS MAY HAVE BEEN AFFECTED BY LOWER THAN EXPECTED CYCLOSPORINE RESULTS. ACCORDING TO (B) (6) NEWS RELEASES, 8 OF THE 212 PTS ARE DECEASED; 3 OF THE 8 DECEASED ARE CONFIRMED UNRELATED TO THIS EVENT AND THE REMAINING 5 ARE UNK. ADDITIONALLY, A (B) (6) BROADCASTING CORP ((B) (6)) NEWS ARTICLE ABOUT THE ISSUE AT (B) (6) REPORTED THAT ONE (B) (6) MALE PT WHO RECEIVED AN EXCESSIVE AMOUNT OF CYCLOSPORINE WAS ADMITTED TO INTENSIVE CARE, ALTHOUGH EH'S NEWS RELEASES HAVE NOT CONFIRMED OR DENIED THIS. THIS MDR IS BEING FILED BASED ON (B) (6) NEWS RELEASES AND THE (B) (6) NEWS ARTICLES AS (B) (6) HAS NOT REPORTED ANY PT ADVERSE EVENTS TO WATERS. WATERS EVALUATED THE QUATTRO PREMIER AT (B) (6) FACILITY PRIOR TO (B) (6) NEWS RELEASES AND DETERMINED THAT IT WAS FUNCTIONING ACCORDING TO ITS SPECIFICATIONS. THE SUMMARY PROVIDED BELOW IS BASED ON WATERS RECORDS, EXCEPT AS NOTED. (B) (6) REQUESTED PROPOSALS FOR A NEW TANDEM MASS SPECTROMETER FROM VARIOUS MANUFACTURERS. ON JULY 15, 2008, WATERS RESPONDED IN A TENDER BY PROVIDING A QUOTE FOR A WATERS QUATTRO PREMIER XE MASS SPECTROMETER (QUATTRO PREMIER). IN APRIL 2009, A WATERS SERVICE TECHNICIAN INSTALLED THE QUATTRO PREMIER AT (B) (6) IN (B) (6). IN JUNE 2009, ACCORDING TO (B) (6) MARCH 9, 2010 NEWS RELEASE, (B) (6) VALIDATED THEIR HOME BREW ASSAY ON THE QUATTRO PREMIER AND THE QUATTRO PREMIER WAS PUT INTO ROUTINE SERVICE FOR CYCLOSPORINE TESTING. ON FEBRUARY 19, 2010, AN (B) (6) LABORATORY MGR CONTACTED A WATERS CLINICAL/FORENSIC MASS SPECTROMETRY (MS) SPECIALIST TO DISCUSS AN ISSUE WITH A SPECIFIC PT'S CYCLOSPORINE A MEASUREMENT. THE WATERS MS SPECIALIST RECOMMENDED THE LAB USE A (B) (4) RESEARCH USE ONLY KIT TO RETEST THIS PT IN ORDER TO ASSESS THE SITUATION. WHEN THE LAB DECLINED, THE MS SPECIALIST RECOMMENDED (B) (6) USE ASCOMYCIN AS AN INTERNAL STANDARD. ON FEBRUARY 25, 2010, (B) (6) CONTACTED WATERS AND REQUESTED ASSISTANCE RETRIEVING AND BACKING UP SOFTWARE FILES FROM THE QUATTRO PREMIER WORKSTATION. ON FEBRUARY 26, 2010, (B) (6) CONTACTED THE WATERS DIRECTOR OF (B) (4)) REQUESTING INFO ABOUT THE QUATTRO PREMIER INSTRUMENT IT PURCHASED, SUCH AS A COPY OF THE PURCHASE ORDER, CONFIRMATION OF THE SERIAL NUMBERS OF ALL THE COMPONENTS INSTALLED, SERVICE HISTORY, ETC. AT THAT TIME, THE WATERS DIRECTOR WAS INFORMED THAT OVER 200 PTS MAY HAVE BEEN AFFECTED BY LOWER THAN EXPECTED CYCLOSPORINE VALUES. HOWEVER, THE WATERS DIRECTOR WAS NOT NOTIFIED THAT ANY ADVERSE EVENTS OCCURRED. THE REQUESTED INSTRUMENT INFO WAS SENT TO EH BY WATERS. ON MARCH 1, 2010, (B) (6) REQUESTED THAT WATERS ASSESS THE PERFORMANCE OF ITS QUATTRO PREMIER. ON MARCH 5, 2010, A WATERS SERVICE ENGINEER ASSESSED THE PERFORMANCE OF THE QUATTRO PREMIER INSTALLED AT THE (B) (6) LABORATORY AND DETERMINED, IT WAS FUNCTIONING WITHIN SPECIFICATION. ON MARCH 9, 2010, (B) (6) PUBLISHED A NEWS RELEASE REGARDING THE LOWER THAN EXPECTED CYCLOSPORINE RESULTS. DETAILS ABOUT THE PTS IMPACTED BY THE LOWER THAN EXPECTED CUCLOSPOTINE RESULTS, PROVIDED BELOW, ARE BASED ON (B) (6) NEWS RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRO PREMIER XE MASS SPECTROMETER MASS SPECTROMETER, CLINICAL USE OQS WATERS CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death| H| L