BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    API 3200MD SYSTEM

    MDR report key: 7039888 · Received November 16, 2017

    Report

    Report Number
    3008935545-2017-00001
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 19, 2017
    Report Date
    August 8, 2019
    Manufacturer
    AB SCIEX
    Product Code
    DOP
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    [NOTE: THE BELOW THREE PARAGRAPHS ARE INFORMATION THAT WAS SUCCESSFULLY SUBMITTED TO FDA ON 16 APRIL 2018. THIS DATA FROM SUPPLEMENT/ FOLLOW-UP REPORT 1 WAS PUT "ON HOLD" (AFTER AB SCIEX RECEIVED THREE SUCCESSFUL ACKNOWLEDGEMENT RECEIPTS) DUE TO A TYPO WITHIN "MFR REPORT #" FIELD: 3008935-2017-0001. EMAIL COMMUNICATION WITH FDA IN JUNE 2019, CONFIRMING RE-SUBMITTAL OF SUPPLEMENT/ FOLLOW-UP REPORT #1 CONTAINING ORIGINAL INFORMATION FROM 16 APRIL 2018 AS WELL AS CLARIFICATION/TYPO FIX OF "MFR REPORT #"]: NOTE, THE MANUFACTURE DATE (13-AUG-2004) WAS ENTERED INCORRECTLY IN THE INITIAL REPORT (3008935545-2017-00001) SUBMITTED TO FDA ON 16-NOV-2017. THIS WAS ORIGINALLY CORRECTED IN THE 16 APRIL 2018 SUPPLEMENT #1 REPORT (3008935-2017-0001), WHICH WAS PUT "ON HOLD" DUE TO TYPO WITHIN "MFR REPORT #" FIELD. THIS REPORT CONTAINS THE SAME CORRECTION THE MANUFACTURE DATE FROM 13-AUG-2004 TO 01-AUG-2013. THE INVESTIGATION ON THE ISSUE OF THE HIGH BACKGROUND NOISE FOR THE METHIONINE D3 ANALYTE ON THE 32000MD SYSTEM HAS BEEN CONCLUDED. WITH REGARDS TO THE REPORTED HIGH METHIONINE D3 BACKGROUND, REPAIR EFFORTS WERE MADE ON BOTH THE HPLC AND THE MASS SPECTROMETER. THE HIGH BACKGROUND SIGNAL HAS BEEN A PERSISTENT ISSUE THROUGHOUT 2017, OVER THE YEAR NINE REPAIR VISITS HAVE BEEN DONE IN ORDER TO ROOT OUT THE ISSUE. DURING MOST OF THESE VISITS CONTAMINATION THROUGHOUT THE SYSTEM HAD BEEN FOUND, THIS LED TO VARIOUS SYMPTOMS IN THE AUTOSAMPLER, THE HPLC AND THE MASS SPECTROMETER AND RESULTING IN POOR PEAK SHAPES. AFTER MULTIPLE CLEANING EFFORTS, IN OCTOBER 2017 SEVERAL PARTS OF THE HPLC SYSTEM WERE REPLACED TO RULE OUT ANY BUILDUP OF PARTICLES/CONTAMINATION WHICH MIGHT BE CAUSING THE BACKGROUND NOISE. IT CONCERNED THE NEEDLE, NEEDLE SEAL, A HIGH PRESSURE VALVE ROTOR AND PEEK TUBING. SECONDLY, THE API3200MD MASS SPECTROMETER FRONT END WAS CLEANED TO RESOLVE ANY CONTAMINATION WORKING THROUGH THE HPLC. DESPITE OUR BEST EFFORTS, IN NOVEMBER AND DECEMBER THE CONTAMINATION AND POOR RESULTS RETURNED AGAIN. THE UNSATISFACTORY OPERATIONS OF THE SYSTEM IN QUESTION HAS RESULTED IN THE RETURN OF THE INSTRUMENT AND WILL NO LONGER BE USED FOR CLINICAL DETERMINATIONS. SCIEX HAS INVESTED SIGNIFICANT EFFORT IN TRYING TO RETRIEVE THE REPORTED QC RESULT IN ORDER TO FURTHER THE INVESTIGATION INTO A POSSIBLE WRONGFUL INTERPRETATION OF THE CHEMOVIEW MD V 2.0.3 SOFTWARE. THE INSTITUTE, (B)(6) HOSPITAL, WAS NOT ABLE TO PROVIDE THE MENTIONED RESULTS AS IT WOULD CONSTITUTE A BREACH OF THEIR PATIENTS' PRIVACY RIGHTS. WE HAVE REVIEWED OUR COMPLAINTS DATABASE ON ALL COMPLAINTS WITH MENTION OF CHEMOVIEW, THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REGARDING INCORRECT RESULTS. WITH THE DATA AVAILABLE WE CANNOT CONCLUDE ANY SOFTWARE ERROR AT THIS TIME. SCIEX WILL CONTINUE TO MONITOR THE RELIABILITY OF OUR PRODUCTS AND IMPROVE ON THEM WHERE POSSIBLE. SINCE INVESTIGATION INTO THIS CASE HAS BEEN COMPLETED AND CLOSED UNDER GOOD FAITH EFFORTS, THIS COMPLETES THE EMDR SUBMISSION. [NOTE: UPDATED SUPPLEMENT #1/ FOLLOW-UP REPORT #1 SUBMITTED 08 AUGUST 2019 WITH TYPO CORRECTION OF "MFR REPORT #" AS WELL AS ADDITIONAL CLARIFICATION. SEE BELOW TWO PARAGRAPHS FOR UPDATED SUPPLMENT #1/ FOLLOW-UP REPORT #1 INFORMATION]: UPON REVIEW OF THIS EMDR CASE SUBMITTED IN 2017: INITIAL REPORT (SUBMITTED 16-NOV-2017) AND SUPPLEMENT/ FOLLOW-UP REPORT #1 (3008935-2017-00001-S1 SUBMITTED 16-APR-2018), IT WAS DETERMINED THAT THERE WAS A TYPO IN THE "MFR REPORT #" (TOP RIGHT CORNER OF FORM 3500A) AND "MANUFACTURER REPORT NUMBER" WITHIN THE SUPPLEMENT/ FOLLOW-UP REPORT #1 (3008935-2017-00001-S1). AS COMMUNICATED BY FDA VIA EMAIL THE ORIGINAL SUPPLEMENT/ FOLLOW-UP REPORT #1 (FROM 16-APR-2018) WAS PUT "ON HOLD" FROM FDA'S END; HOWEVER AB SCIEX RECEIVED 3 ACKNOWLEDGEMENT RECEIPTS FOR 3008935-2017-00001-S1 INDICATING A SUCCESSFUL SUBMISSION THROUGH WEBTRADER. THERE WAS NO INDICATION THAT THE SUBMISSION WAS PUT "ON HOLD." FDA CONFIRMED THERE WAS A SOFTWARE BUG WITHIN WEBTRADER THAT WAS PRESENT IN 2018, WHICH HAS NOW BEEN RESOLVED. FDA AGREED AND RECOMMENDED THAT AB SCIEX SHOULD RE-SUBMIT ALL CORRECTED INFORMATION REGARDING EMDR CASE 3008935545-2017-0001 VIA WEBTRADER AS AN UPDATED SUPPLEMENT/ FOLLOW-UP REPORT #1. THIS REPORT CONTAINS ALL CORRECTED INFORMATION ORIGINALLY SUBMITTED AS 3008935-2017-00001-S1. PLEASE OBSOLETE THE ORIGINAL SUPPLEMENT/ FOLLOW-UP REPORT #1 (3008935-2017-00001-S1) WHICH WAS SUBMITTED TO FDA ON 16-APR-2018 AND WAS PUT "ON HOLD". THIS COMPLETES THE EMDR SUBMISSION.

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF PATIENT INJURY OR DEATH. THE EVENT HAPPENED DURING TESTING OF CONTROL SAMPLES. IF THIS WERE TO RE-OCCUR ON ACTUAL PATIENT SAMPLES THERE IS A POTENTIAL FOR WRONG RESULTS WHICH COULD LEAD TO DELAYED RESULTS/MISDIAGNOSIS. THE INVESTIGATION OF THE COMPLAINT IS ONGOING AND A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE INSTRUMENT INVOLVED, A API 3200MD LC-MS/MS SYSTEM, HAD SHOWN HIGH BACKGROUND NOISE FOR THE METHIONINE D3 ANALYTE. THE SOFTWARE, CHEMOVIEW MD V2.0.3, WAS NO LONGER ABLE TO RECOGNIZE THE SIGNAL PEAKS FOR THE METHIONINE D3 ANALYTE DUE TO THIS BACKGROUND NOISE. DURING A REPAIR ATTEMPT THE CUSTOMER RAN FOUR QUALITY CONTROLS TO TEST THE SYSTEM. ONE QUALITY CONTROL FAILED ON ONE ANALYTE DUE TO SPIKE OF BACKGROUND NOISE AT START OF INJECTION. THIS CAUSED CHEMOVIEW MD TO GIVE THE WRONG RESULT. IT WAS MENTIONED BY THE CUSTOMER THAT IF THIS HAD OCCURRED DURING AN ACTUAL PATIENT SAMPLE RUN, IT MIGHT HAVE GONE UNNOTICED. THE CUSTOMER WAS USING THIS INSTRUMENT TO RUN NEWBORN SCREENING TESTS USING THE CHROMSYSTEMS NEWBORN SCREENING KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817571 API 3200MD SYSTEM LC-MS/MS DOP AB SCIEX API3200MD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other