BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 GASTRIN

    MDR report key: 23210077 · Received October 3, 2025

    Report

    Report Number
    1219913-2025-00179
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 7, 2025
    Report Date
    November 19, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD.
    Product Code
    CGC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2025-00179 ON 03-OCT-2025. ADDITIONAL INFORMATION (13-NOV-2025): THE CUSTOMER USES THEIR OWN MEAN AND STANDARD DEVIATION VALUES. INSTABILITY OF THE PRIMARY REAGENT PACK CANNOT BE RULED OUT AS A POTENTIAL CAUSE OF THE EVENT. ERROR LOG EVALUATION REVEALED REPEATEDLY THE FOLLOWING TWO ERRORS DURING THE REPORTED TIME PERIOD: ERROR 528 (PIPETTOR - LMIMOVEMOTOR HAS TIP JAM- INDICATES THAT A MOTOR MOTION FOR A FIXED DISTANCE, WITH TIP JAM ACTIVATED HAS RETURNED A TIP JAM ERROR) AND ERROR 633 (DILUTION WELL - CLEAN DILUTION WELL FAIL-SAFE TRIGGERED - A SAMPLE ERROR RESULTED IN THE NEED TO CLEAN THE DILUTION WELL OR THE DILUTION WELL INSERT IS NOT FULLY SEATED). SPY FILE EVALUATION SHOWED THAT TWO REAGENT WEDGES WERE ONBOARD BUT ONLY ONE WEDGE WITH SERIAL AJM WAS IN USE FOR THE REPORTED PERIOD. ENCODER VALUES FOR THE REAGENT LEVEL SENSING DID NOT REVEAL ANY OCCURRENCES OF FOAM OR BUBBLES ON THE REAGENT. DELTA VALUES BETWEEN THE DIFFERENT REAGENT ASPIRATION STEPS ARE AS EXPECTED. THE DIFFERENCE IN SUCCESSIVE LEVEL SENSE, THE DELTA, REFLECTS HOW MUCH REAGENT WAS REMOVED WHEN THE REAGENT WAS ASPIRATED THE PREVIOUS TIME. AN INSTABILITY OR CONTAMINATION OF THE GASTRIN REAGENT WITH SERIAL AJM CANNOT BE RULED OUT. SIEMENS ALSO RECOMMENDS TO THE CUSTOMER A SERVICE VISIT FOR CHECKING PROBE ALIGNMENTS AND PROCEEDING A DECONTAMINATION. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CALIBRATION IN EFFECT AT THE TIME OF SAMPLE PROCESSING WAS PERFORMED ON (B)(6) 2025 AT 00:24. NO QUALITY CONTROL (QC) WAS PROCESSED IMMEDIATELY AFTER CALIBRATION; HOWEVER, THE QC PROCESSED AT 11:13 ON (B)(6) 2025 WAS WITHIN THE ACCEPTANCE RANGE. DURING THE RESET PERIOD, ONE CONTROL FAILURE WAS OBSERVED FOR ON (B)(6) 2025 AT 11:47. IT IS BELIEVED THAT THE CONTROL FAILURE AND THE OBSERVED BIAS OCCURRED WITHIN THE SAME REAGENT PACK, ALTHOUGH IT WAS NOT POSSIBLE TO TRACE THE EXACT PACK ON SITE. THE EVENT LOG WAS REVIEWED AND NO ERROR MESSAGES WERE OBSERVED, SUGGESTING THAT NO MECHANICAL ISSUES WERE OBSERVED DURING THE PERIOD. SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT A FALSELY LOW GASTRIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 GASTRIN REAGENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ANALYZER, RECOVERING HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO FALSELY LOW GASTRIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457672 IMMULITE 2000 GASTRIN RADIOIMMUNOASSAY, GASTRIN CGC SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD. IMMULITE 2000 GASTRIN 335

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female