BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 7961151 · Received October 12, 2018

    Report

    Report Number
    3002637618-2018-00120
    Event Type
    Death
    Date Received
    October 12, 2018
    Date of Event
    July 23, 2018
    Report Date
    October 12, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: WE WERE REQUIRED TO FILE A MANUFACTURER'S INCIDENT REPORT (MIR) WITH (B)(6) BECAUSE SIEMENS RP 500 ANALYZER WAS IN USE AT THE TIME OF THE ADVERSE EVENT. WE ARE FILING THIS MDR TO COINCIDE WITH THE MIR. THE CUSTOMER CONFIRMED THAT THE ANALYZER DID NOT MALFUNCTION, AND IT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE CUSTOMER IS NOT QUESTIONING THE PERFORMANCE OF THE ANALYZER, AND THEY CONTINUE TO USE THIS SPECIFIC DEVICE FOR PATIENT CARE. SIEMENS HAS CONDUCTED AN INVESTIGATION INTO THE RAPIDPOINT 500 ANALYZER THAT WAS USED FOR TESTING AT THE TIME OF THIS INCIDENT AND HAS DETERMINED THE FOLLOWING: ALTHOUGH THIS EVENT OCCURRED ON (B)(6) 2018, SIEMENS WAS NOT NOTIFIED UNTIL SEPTEMBER 25, 2018 VIA THE (B)(6) ADVERSE INCIDENT REPORT. THE CUSTOMER STATED THAT THE RAPIDPOINT 500 BLOOD GAS ANALYZER THAT WAS IN USE AT THE TIME OF THIS INCIDENT WAS NOT TAKEN OUT OF SERVICE AND IS CURRENTLY IN USE. THE CUSTOMER HAS NOT PROVIDED ANY TEST RESULTS. THE CUSTOMER CONFIRMED THAT THEY ARE NOT QUESTIONING THE PERFORMANCE OF THE ANALYZER OR THAT THE ANALYZER MALFUNCTIONED. SERVICE HISTORY RECORDS WERE PROVIDED FOR THE RP 500, S/N (B)(4) SINCE (B)(6) 2018. THERE WERE NO SERVICE CALLS RELATED TO GLUCOSE FROM (B)(6) 2018 THROUGH (B)(6) 2018. THE ANALYZER WAS OPERATING AS INTENDED. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA. THE GLUCOSE PERFORMANCE FOR THE MEASUREMENT CARTRIDGE WAS STABLE OVER USE LIFE. AQC FOR ALL THREE LEVELS HAD NO OUT OF RANGE VALUES OVER USE LIFE OF THE MEASUREMENT CARTRIDGE. UPON BEING NOTIFIED OF THIS EVENT, SIEMENS SERVICE WENT ONSITE AND PERFORMED A TOTAL SERVICE CALL WHICH INCLUDED CHECKING AND VERIFYING THE ALIGNMENT OF THE MEASUREMENT AND AQC ACTUATORS, CLEANING THE AIR FILTER, INSTALLING A NEW WASH/WASTE CARTRIDGE AND RUNNING SEVERAL CALIBRATIONS. AND, AGAIN, ALL THREE LEVELS OF AQC WERE IN THE EXPECTED RANGES. THERE WAS NO INDICATION OF ANY MALFUNCTION. THE CUSTOMER STATES THAT THE RP 500 DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

    Description of Event or Problem · 1

    SIEMENS HAS RECEIVED AN ADVERSE INCIDENT REPORT FROM (B)(6). POLICE ARE CURRENTLY INVESTIGATING THE SUDDEN DEATH OF A PATIENT AT THE (B)(6) HOSPITAL IN (B)(6). THE RP 500 WAS IN USE AT THE TIME. PER THE DETECTIVE CONSTABLE INVESTIGATING THIS EVENT: "ON (B)(6) 2018 A PATIENT AT THE ICU, WAS SCHEDULED FOR A TRACHEOSTOMY OPERATION. SHE HAD TYPE 1 DIABETES AND WAS ON AN INSULIN DRIP, AND HAD A NASO-GASTRIC FEED FITTED. BOTH SHOULD HAVE BEEN STOPPED PRIOR TO HER OPERATION, BUT IT TRANSPIRES THAT SHE WAS GIVEN AN OVERDOSE OF INSULIN WHICH CAUSED HER GLUCOSE TO DROP SIGNIFICANTLY. THIS SHOULD HAVE BEEN RECOGNISED THROUGH HOURLY OR TWO HOURLY BLOOD TESTS USING A VENOUS GAS ANALYSER (VGA) AND A GLUCOMETER, BUT ALTHOUGH TESTS WERE CONDUCTED, THE LOW LEVELS WERE NOT IDENTIFIED BY STAFF. DETAILS OF THE PATIENT'S INJURY: SEVERE HYPOGLYCAEMIA RESULTING IN SERIOUS BRAIN INJURY TO PATIENT, WHO LATER DIED AFTER SUPPORT WAS WITHDRAWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802310 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death