BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 17058652 · Received June 5, 2023

    Report

    Report Number
    2432235-2023-00136
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 3, 2023
    Report Date
    August 28, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT THE HEMOLYSIS, ICTERIC, AND LIPEMIA (HIL) TESTS DID NOT COMPLETE ON THE ATELLICA CH 930 ANALYZER. THE INSTRUMENT SENT DUPLICATE NOTIFICATIONS TO THE LABORATORY INFORMATION SYSTEM (LIS) AFTER A SAMPLE BARCODE READ ERROR ON THE INITIAL IDENTIFICATION, WHICH NEEDED A "TUBE SWAP" AND SECOND IDENTIFICATION WHERE THE BARCODE WAS CORRECTLY READ. THIS RESULTED IN A DUPLICATE HIL ORDER THAT WAS LEFT IN PROCESS. RESULTS FOR ALL THE TESTS, EXCEPT HIL, WERE AVAILABLE ON THE WORKLIST. IN THE EVENT OF AN URGENT REQUEST, THE PATIENT¿S TEST RESULTS WOULD HAVE BEEN AVAILABLE OFF THE ANALYZER WITHOUT ANY DELAYS. ACCORDING TO GOOD LABORATORY AND CLINICAL PRACTICE, TURNAROUND TIME (TAT) OF ALL SAMPLES, ESPECIALLY ANY EMERGENCY OR STAT SAMPLES OR SPECIMEN ORDERS WOULD GENERALLY BE CLOSELY MONITORED BY THE LABORATORY AND THE TREATING PHYSICIAN. TAT MONITORING IS DONE TO ENSURE PROMPT PATIENT CARE AS REQUIRED BY THE CLINICAL SETTING, SO THE 2-HOUR DELAY WOULD BE APPARENT TO THE CUSTOMER. THIS WOULD BE MITIGATED BY STANDARD POLICIES AND PROCEDURES THAT WOULD BE IN PLACE TO ENSURE UNINTERRUPTED PATIENT CARE. MITIGATIONS FOR A DELAY ON AUTOMATED HIL ASSESSMENTS INCLUDE THE MANUAL GROSS INSPECTION OF THE SAMPLE WHICH WOULD MAKE AN ISSUE OF ANY POTENTIAL HIL INTERFERENCE EVIDENT TO THE CUSTOMER AND NECESSARY MITIGATIONS WOULD BE TAKEN TO PREVENT ANY DELAY IN PATIENT RESULT GENERATION. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THIS VISIT, THE CSE CLEANED THE RETROREFLECTIVE PLATE AND FOCUSED THE CAMERAS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR (B)(4) ON 05-JUN-2023. AS INDICATED IN THE INITIAL REPORT, THE INSTRUMENT SENT DUPLICATE NOTIFICATIONS/QUERIES TO THE LABORATORY INFORMATION SYSTEM (LIS) AFTER A SAMPLE BARCODE READ ERROR ON THE INITIAL IDENTIFICATION, WHICH NEEDED A "TUBE SWAP" AND SECOND IDENTIFICATION WHERE THE BARCODE WAS CORRECTLY READ. THIS RESULTED IN A DUPLICATE HIL ORDER THAT WAS LEFT IN PROCESS. ADDITIONAL INFORMATION (04-AUG-2023): SIEMENS FURTHER INVESTIGATED THE ISSUE AND DETERMINED THE ATELLICA DATA MANAGER (ADM) AND LIS EXPECTED ONE QUERY PER PATIENT SAMPLE. WHEN DUPLICATE QUERIES ARE SEEN, THE ADM CAN POST A 'NO RESULT' ERROR FOR TEST RESULTS AND HEMOLYSIS (H), ICTERIC (I), AND LIPEMIA (L) TESTS REMAIN IN PROCESS ON THE WORKLIST SCREEN. THE ANALYZER GENERATES ERROR CODES, INDICATING THAT THE INSTRUMENT CANNOT COMPLETE THE REQUEST FROM THE LIS BECAUSE TESTS ARE IN PROCESS. THE CUSTOMER BECOMES AWARE OF THIS ISSUE WHEN 'NO RESULT' IS POSTED FOR SAMPLES IN THE ADM AND FOR HIL TESTS AND THIS MAY RESULT IN THE HIL TESTING PENDING. IF THE SYSTEM IS CONFIGURED TO HOLD TEST RESULTS UNTIL THE HIL RESULTS ARE COMPLETED, RESULTS FOR THOSE ASSAYS WILL NOT TRANSMIT TO THE ADM/LIS AUTOMATICALLY AND ARE FLAGGED WITH 'WAITING FOR HIL' ON THE WORKLIST. IF THE SAMPLE IS RELOADED OR IF HIL TESTING IS REPEATED, THEN HIL PROCESSING IS COMPLETED. THE PATIENT TEST RESULT IS AVAILABLE ON THE ATELLICA SOLUTION DISPLAY AND THE TEST RESULT WILL BE TRANSMITTED BY THE ATELLICA SOLUTION ONCE COMPLETED. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS ANALYZER IS NEEDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE HEMOLYSIS, ICTERIC, AND LIPEMIA (HIL) TESTS DID NOT COMPLETE ON THE ATELLICA CH 930 ANALYZER. THE INSTRUMENT GENERATED A FLAG INDICATING THE INSTRUMENT WAS WAITING FOR HIL RESULTS. THE PATIENT SAMPLE DETAILS INDICATED THE SAMPLES COMPLETED TESTING FOR ALL ASSAYS ORDERED EXCEPT FOR HIL. THERE WAS AN HOURGLASS PRESENT NEXT TO THE HIL TEST. THE SAMPLE ID WAS READ AT THE TUBE CHARACTERIZATION STATION AT 07:18:50AM ON (B)(6) 2023. THE SAMPLE REMAINED ONBOARD UNTIL 08:21:58AM ON (B)(6) 2023 WHEN IT WAS REMOVED FROM THE SYSTEM. THE CUSTOMER NOTICED THE SAMPLE WAS PENDING IN THE PENDING LOG AND PLACED THE SAMPLE ON AN ALTERNATE ATELLICA CH 930 ANALYZER AND RESULTED WITHIN MINUTES. THERE WAS A 2-HOUR DELAY IN REPORTING RESULTS. THE RESULTS WERE AVAILABLE ON THE WORKLIST BUT WERE NOT SENT OVER THE LABORATORY INFORMATION SYSTEM (LIS). THERE WERE NO DISCORDANT RESULTS BETWEEN THE TWO ANALYZERS. THE CUSTOMER REPORTED THAT THE PATIENT HAD AN UNFAVORABLE OUTCOME AND THE PATIENT HAD EXPIRED. THE CUSTOMER DID NOT INDICATE THE PATIENT EXPIRATION IS RELATED TO THE DELAY IN TEST RESULTS. THIS MDR IS BEING FILED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183143 ATELLICA CH 930 ANALYZER ATELLICA CH 930 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA CH 930 ANALYZER 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male