BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 3000

    MDR report key: 5498598 · Received March 14, 2016

    Report

    Report Number
    1217183-2016-00001
    Event Type
    Death
    Date Received
    March 14, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 3, 2016
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K052121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IL PERFORMED AN INVESTIGATION, REVIEWING THE GEM PREMIER 3000 INSTRUMENT DATA BACK-UP, AND DETERMINED THE FOLLOWING: 1. AN LIS SOFTWARE MIS-COMMUNICATION CAUSED THE REPORTED INCIDENT. SPECIFICALLY, THE LIS DID NOT TREAT THE GEM PREMIER 3000 TRANSMISSION OF SAMPLE INFORMATION ACCORDING TO SOFTWARE STANDARD (B)(4). THEREFORE, PARTIAL TRANSMISSION OF RESULTS FROM GEM PREMIER 3000 WITH SAMPLE #1, PROPERLY FLAGGED BY THE INSTRUMENT AS INCOMPLETE, WAS INCORRECTLY ACCEPTED AS COMPLETE BY THE LIS SOFTWARE AND CONSEQUENTLY THE SAMPLE RESULTS POSTED TO THE LIS. THE GEM PREMIER 3000 SOFTWARE APPROPRIATELY AWAITED TRANSMISSION ACKNOWLEDGMENT FROM THE LIS SOFTWARE AND WHEN NOT RECEIVED, THE INSTRUMENT CONTINUED TO RESEND THE SAME SAMPLE # 1 RESULT, CREATING MULTIPLE POSTING OF THE SAME RESULT. 2. THE LIS SOFTWARE ALSO FAILED TO FLAG THESE SAMPLES AS IDENTICAL, LEADING THE CUSTOMER TO BELIEVE DIFFERENT SAMPLE RESULTS WERE BEING REPORTED. IN CONCLUSION, THE GEM PREMIER 3000 PERFORMANCE MET ALL SPECIFICATIONS WITH NO MALFUNCTION. THE INCIDENT IN QUESTION WAS THE RESULT OF AN LIS COMMUNICATION ISSUE BECAUSE THE LIS VENDOR DID NOT FOLLOW THE MANDATED (B)(4) PROTOCOL. THEREFORE, THE SITUATION RESULTED FROM THE CUSTOMER'S LIS SET-UP AND NO REMEDIAL ACTION IS INDICATED FOR THE GEM PREMIER 3000. IL WILL CONTACT THE CUSTOMER TO ADVISE THEM OF THE LIS SITUATION AND REQUEST THAT THEY REVIEW THE MATTER WITH THE VENDOR. AS A FURTHER PREVENTIVE MEASURE, IL WILL INTRODUCE A SOFTWARE ENHANCEMENT IN A FUTURE RELEASE THAT WOULD PREVENT THIS SAME LIS COMMUNICATION MALFUNCTION FROM REOCCURRING. INSTRUMENT BACK UP REVIEWED.

    Description of Event or Problem · 1

    AN IL REPRESENTATIVE REPORTED THAT A CUSTOMER'S GEM PREMIER 3000 REPEATEDLY SENT THE SAME SAMPLE RESULT THROUGH THEIR LIS ((B)(4)). THE INCIDENT INVOLVED A PATIENT UNDER VENTILATOR TREATMENT WITH A DIAGNOSIS OF ACIDOSIS. THERE WERE A TOTAL OF 4 DIFFERENT SAMPLES TAKEN FROM THIS PATIENT ON (B)(6) 2016, AT THE FOLLOWING TIMES: SAMPLE #1 @ 13:09, SAMPLE #2 @14:14, SAMPLE #3 @ 15:36 AND SAMPLE #4 @ 21:39. THE SAME SAMPLE RESULT OBTAINED AT 13:09 (SAMPLE #1) ON THE GEM PREMIER 3000 WAS REPORTED THREE ADDITIONAL TIMES THROUGH THE LIS ((B)(4)). THE ISSUE WAS NOT IDENTIFIED UNTIL SAMPLE #4 @21:39. AT THAT TIME, THE THERAPIST OPERATING THE VENTILATOR REPORTED THAT THE RESULTS FOR SAMPLE #4 FROM THE LIS DID NOT MATCH THE REPORTED SAMPLE RESULT FOR SAMPLE #4 FROM THE GEM PREMIER 3000 INSTRUMENT. IN REVIEWING THE DATA, THE FOUR SAMPLE RESULTS WERE VERY SIMILAR WITH UNLIKELY IMPACT ON PATIENT OUTCOME. THE PATIENT IN QUESTION WAS IN CRITICAL CONDITION AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153694 GEM PREMIER 3000 CLINCAL CHEMISTRY INSTRUMENT CHL INSTRUMENTATION LABORATORY CO. 2257

    Patients

    Seq Age Sex Outcome Treatment
    1 Death